Bone graft delivery system and method for using same

ABSTRACT

The present invention relates to an apparatus, system and method for delivery of bone graft material in a patient&#39;s spine. The graft delivery device according to various embodiments delivers and disperses biologic material to a disc space and without withdrawal from the surgical site. In various embodiments, the graft delivery device includes an elongate hollow tube configured to receive bone graft material, a plunger adapted to extend in the elongate hollow tube and urge the bone graft material through the elongate hollow tube, and an injection device (such as a syringe) configured to contain the bone graft material therein and to connect to an open proximal end of the elongate hollow tube, to discharge the bone graft material from the first injection device into the elongate hollow tube.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/419,883, filed on Jun. 30, 2021, which is the U.S. national phaseentry of International Patent Application No. PCT/US20/21451, filed onMar. 6, 2020, and also claims the benefit of U.S. Provisional PatentApplication No. 62/815,245, filed on Mar. 7, 2019. The disclosures ofall of the aforementioned applications are incorporated herein byreference in their entirety.

FIELD OF THE INVENTION

This disclosure relates to orthopedic surgery, and more specifically toan apparatus and method for delivery of bone graft material into apatient, for example, during the placement of surgical cages or othermedical implants in a patient's spine.

BACKGROUND OF THE INVENTION

According to the American Academy of Orthopedic Surgeons, about 250,000spinal fusion surgeries are performed every year, mostly on adultsbetween the ages of 45 to 64. Spinal fusion is a process by which two ormore of the vertebrae that make up the spinal column are fused togetherwith bone grafts and internal devices (such as rods) that heal into asingle solid bone. Spinal fusion can eliminate unnatural motion betweenthe vertebrae and, in turn, reduce pressure on nerve endings. Inaddition, spinal fusion can be used to treat, for example, injuries tospinal vertebrae caused by trauma; protrusion and degeneration of thecushioning disc between vertebrae (sometimes called slipped disc orherniated disc); abnormal curvatures (such as scoliosis or kyphosis);and weak or unstable spine caused by infections or tumors.

Individuals who suffer from degenerative disc disease, natural spinedeformations, a herniated disc, spine injuries or other spine disordersmay require surgery on the affected region to relieve the individualfrom pain and prevent further injury to the spine and nerves. Spinalsurgery may involve removal of damaged joint tissue, insertion of atissue implant and/or fixation of two or more adjacent vertebral bodies.In some instances, a medical implant is also inserted, such as a fusioncage. The surgical procedure will vary depending on the nature andextent of the injury. Generally, there are five main types of lumbarfusion, including: posterior lumbar fusion (“PLF”), posterior lumbarinterbody fusion (“PLIF”), anterior lumbar interbody fusion (“ALIF”),circumferential 360 fusion, and transforaminal lumbar interbody fusion(“TLIF”). More recently, direct lateral interbody fusion (“D-LIF”) hasbecome available. A posterior approach is one that accesses the surgicalsite from the patient's back, an anterior approach is one that accessesthe surgical site from the patient's front or chest, and a directlateral approach is one that accesses the surgical site from thepatient's side. There are similar approaches for fusion in the interbodyor cervical spine regions. For a general background on some of theseprocedures and the tools and apparatus used in certain procedures, seeU.S. Prov. Pat. Appl. No. 61/120,260 filed on Dec. 5, 2008, the entiredisclosure of which is incorporated by reference in its entirety. Inaddition, further background on procedures and tools and apparatus usedin spinal procedures is found in U.S. Pat. Appl. 12/632,720 filed onDec. 7, 2009, now U.S. Pat. No. 8,366,748, the entire disclosure ofwhich is incorporated by reference in its entirety.

Vertebrectomy, or the removal or excision of a vertebra, is another typeof spinal surgery that may be necessary to alleviate pain and/or correctspinal defects, such as when disc material above and below a particularvertebra protrudes from the spine and contacts the spinal cord. Once theproblematic vertebra is removed, a specialized fusion cage (also calleda vertebrectomy cage) may be inserted into its place to restorestructural continuity to the spine.

Some disadvantages of traditional methods of spinal surgery include, forexample, the pain associated with the procedure, the length of theprocedure, the complexity of implements used to carry out the procedure,the prolonged hospitalization required to manage pain, the risk ofinfection due to the invasive nature of the procedure, and the possiblerequirement of a second procedure to harvest autograft bone from theiliac crest or other suitable site on the patient for generating therequired quantity of cancellous and/or cortical bone.

A variety of semisolid bone graft materials are available on the marketwhich ostensibly increase spinal fusion rates without the morbidity ofautograft bone harvesting. Each of the manufacturers espouses theirproduct as the most advantageous for healing. Many of these productshave similar handling characteristics and the literature reveals thatthey have similar healing prospects. They come in a syringe and it is upto the surgeon to apply the selected material to the target site. Themost common site for application is to the disc space after it has beenprepared to a bleeding bed and ready to accept a cage and/or thegrafting material. This represents a long and narrow channel even inopen procedures. The surgeon is left to his or her own devices as to howto get the graft from its container to the active site. The deviceswhich have been used have included a “caulking gun” construct and avariety of barrel shaft with a plunger design.

Bone graft typically includes crushed bone (cancellous bone, corticalbone, or a combination of these (and/or other natural materials)), andmay further comprise synthetic biocompatible materials. Bone graft ofthis type is intended to stimulate growth of healthy bone. Another typeof bone graft has a fibrous composition similar in consistency andappearance to a cotton ball. Fibrous bone graft includes interconnectedmacro- and microporous structures that foster development of new boneand nurture the growth of capillary blood vessels. Although fibrous bonegraft provides certain benefits, it can be difficult to deliver to asurgical site due to it compressibility and because its fibers can catchor snag on delivery tools. One example of the fibrous bone graftcomprises beta tricalcium phosphate, calcium carbonate and a resorbablescaffold of Poly-L-lactide that form a biodegradable structure. One typeof fibrous bone graft is marketed as ReBOSSIS® which is produced byORTHOReBIRTH Co. Ltd.

As used herein, “bone graft” shall mean materials made up entirely ofnatural materials, entirely of synthetic biocompatible materials, or anycombination of these materials. Bone graft often is provided by thesupplier in a gel or slurry form, as opposed to a dry or granule form.Many companies provide various forms of bone graft in varying degrees ofliquidity and viscosity, which may cause problems in certain prior artdelivery devices using prepackaged bone graft, or where the bone graftis packaged by the surgeon. In addition, the method of delivery of bonegraft to a particular location varies depending on the form of the bonegraft utilized.

Autogenous bone (bone from the patient) or allograft bone (bone fromanother human being) are the most commonly used materials to induce boneformation. Generally, small pieces of bone are placed into the spacebetween the vertebrae to be fused. Sometimes larger solid pieces of boneare used to provide immediate structural support. Autogenous bone isgenerally considered superior at promoting fusion. However, thisprocedure requires an additional, separate surgery to remove bone fromanother area of the patient's body such as the pelvis or fibula. Thus,it has been reported that about 30 percent of patients have significantpain and tenderness at the graft harvest site, which may be prolonged,and in some cases outlast the back pain the procedure intended tocorrect. Similarly, allograft bone and other bone graft substitutes,although eliminating the need for a second surgery, have drawbacks inthat they have yet to be proven as cost effective and efficacioussubstitutes for autogenous bone fusion.

An alternative to autogenous or allograft bone is the use of growthfactors that promote bone formation. For example, studies have shownthat the use of bone morphogenic proteins (“BMPs”) results in betteroverall fusion, less time in the operating room and, more importantly,fewer complications for patients because it eliminates the need for thesecond surgery. However, use of BMPs, although efficacious in promotingbone growth, can be prohibitively expensive.

Another alternative is the use of a genetically engineered version of anaturally occurring bone growth factor. This approach also haslimitations. Specifically, surgeons have expressed concerns thatgenetically engineered BMPs can dramatically speed the growth ofcancerous cells or cause non-cancerous cells to become more sinister.Another concern is unwanted bone creation. There is a chance that bonegenerated by genetically engineered BMPs could form over the delicatenerve endings in the spine or, worse, somewhere else in the body.

Regenerative medicine, which harnesses the ability of regenerativecells, e.g., stem cells (i.e., the unspecialized master cells of thebody) to renew themselves indefinitely and develop into maturespecialized cells, may be a means of circumventing the limitations ofthe prior-art techniques. Stem cells, i.e., both embryonic and adultstem cells, have been shown to possess the nascent capacity to becomemany, if not all, of the 200+ cell and tissue types of the body,including bone. Recently, adipose tissue has been shown to be a sourceof adult stem cells (See e.g. Zuk, Patricia Z. et al., “MultilineageCells from Human Adipose Tissue: Implication for Cell-Based Therapies,”Tissue Engineering, Apr. 2001, 7:211-28; Zuk, Patricia A. et al., “HumanAdipose Tissue Is A Source Of Multipotent Stem Cells,” Molecular Biologyof the Cell, 2002, 13:4279-4295). Adipose tissue (unlike marrow, skin,muscle, liver and brain) is comparably easy to harvest in relativelylarge amounts with low morbidity (See e.g. Commons, G. W., Halperin, B.,and Chang, C. C. (2001) “Large-volume liposuction: a review of 631consecutive cases over 12 years” Plast. Reconstr. Surg. 108, 1753-63;Katz, B. E., Bruck, M. C. and Coleman, W. P. 3 (2001b) “The benefits ofpowered liposuction versus traditional liposuction: a paired comparisonanalysis” Dermatol. Surg. 27, 863-7). Accordingly, given the limitationsof the prior art spinal fusion techniques, there exists a need for adevice that incorporates regenerative cells, e.g., stem cells thatpossess the ability to induce bone formation.

Many different methods and approaches have been attempted to induce boneformation or to promote spinal fusion. The traditional devices forinserting bone graft impair the surgeon's visualization of the operativesite, which can lead to imprecise insertion of bone graft and possibleharm to the patient. The caulking gun and the collection of largebarrel/plunger designs typically present components at the top of theirstructure which block the view of the surgical site. The surgeon mustthen resort to applying pressure to the surgical site to approximate thelocation of the device's delivery area. Such rough maneuvering canresult in imprecise placement of bone graft, and in some cases, ruptureof the surgical area by penetrating the annulus and entering theabdominal cavity. Also, in some surgical procedures, the devices forinserting bone graft material are applied within a cannula inserted orplaced in the surgical area, further limiting the size and/or profile ofthe bone graft insertion device. When a cannula is involved, sometraditional devices such as the large barrel/plunger designs and/or somecaulking gun designs simply cannot be used as they cannot be insertedwithin the cannula.

Traditional devices for inserting bone graft deliver the bone graftmaterial at the bottom of the delivery device along the device'slongitudinal axis. Such a delivery method causes the bone graftingmaterial to become impacted at the bottom of the delivery device whichjams the device and promotes risk of rupture of the surgical area bypenetrating the annulus and entering the abdominal cavity. Further,traditional devices that deliver bone graft material along theirlongitudinal axis may cause rupture of the surgical area or harm to thepatient because of the ensuing pressure imparted by the ejected bonegraft material from the longitudinal axis of the device. Furthermore,the graft material is distributed only in the longitudinal axis and doesnot fill in the peripheral areas of the disk.

As mentioned, the method of delivery of bone graft to a particularlocation varies depending on the form of the bone graft utilized. Forexample, in the case of slurry type bone graft, various dispensingdevices have been developed having applicators designed to accommodatethis type of bone graft. One such device is disclosed by U.S. Pat. No.5,925,051 issued to Mikhail on Jul. 20, 1999 (“Mikhail”), the disclosureof which is incorporated herein by reference in its entirety. Mikhailprovides a caulking gun type dispenser for introducing bone graft in anenlarged bone (e.g. femoral) cavity. The device preferably includes abarrel pre-loaded with bone graft and a cannulated ejector positionedover a multi-section guide wire. This arrangement purports to accomplishboth ejecting bone graft from the barrel and compacting the bone graftmaterial while being guided on the guide wire. Mikhail, however, isdesigned solely for use with slurry-type bone graft, and does notaccommodate bone graft in granule form, which often varies in size amonggranules and does not have the same “flow” or viscosity characteristicsas slurry-type bone graft. Thus, the applicator of Mikhail isinsufficient for introducing most bone graft to a surgical site in apatient.

U.S. Pat. No. 6,019,765 issued to Thornhill et al. on Feb. 1, 2000(“Thornhill”) also teaches a bone graft delivery device and isincorporated herein by reference in its entirety. The bone graft deviceapplicator of Thornhill is used to apply bone graft to an artificialjoint without having to remove a previously implanted prosthesiscomponent. The applicator device includes a hollow tube with anactuation mechanism for discharging the bone graft from the device via anozzle coupled to a distal end of the tube. The bone graft deliverydevice of Thornhill may include various components for loading thedevice with the bone graft, and may further include a plurality ofnozzles each having a geometry suited for a particular application. LikeMikhail, the Thornhill delivery device is designed for use with boneslurry, and requires much custom instrumentation and different sizedparts to achieve success in many bone graft delivery applications, whichin turn increases the time to assemble and use the delivery device andmay create further problems during the surgical operation.

U.S. Pat. No. 5,697,932 issued to Smith et al. on Dec. 16, 1997(“Smith”) discloses yet another bone graft delivery system and methodand is incorporated herein by reference in its entirety. In Smith, ahollow tube of pre-loaded bone graft and a plunger are used tofacilitate delivery of the bone graft to a bone graft receiving area. Apositioning structure is provided on the plunger to maintain the plungerin a desirable position with respect to the hollow tube. Adjunctpositioning means may also be provided to ensure that the plungerremains in the desirable position during the packing of bone graft intothe bone graft receiving area. Like the devices of Thornhill andMikhail, the device disclosed by Smith is clearly designed solely forslurry type bone graft, and does not provide an effective opening forreceiving the desired amount of bone graft. Furthermore, the hollow tubeshown by Smith is narrow and does not have a footing or other apparatusassociated with the delivery device for preventing the device frompenetrating, for example, the abdominal region of a patient, which mayoccur during tamping or packing of the bone graft. This in turn maycause serious injury to a patient if not controlled, and for thesereasons the device of Smith is also insufficient for delivery of bonegraft to a surgical site.

Traditional devices for inserting a fusion cage or other medicalimplants into a patient's spine or other surgical area are distinct andseparate from traditional devices that deliver bone graft material tothe surgical site. For example, once an implant has been positioned,then bone growth material is packed into the internal cavity of thefusion cage. Also, sometimes the process is reversed, i.e., the bonegrowth is inserted first, and then the implant. These bone growthinducing substances come into immediate contact with the bone from thevertebral bone structures which project into the internal cavity throughthe apertures. Two devices are thus traditionally used to insert bonegraft material into a patient's spine and to position and insert afusion cage. These devices thus necessitate a disc space preparationfollowed by introduction of the biologic materials necessary to inducefusion and, in a separate step, application of a structural interbodyfusion cage.

The problems associated with separate administration of the biologicmaterial bone graft material and the insertion of a fusion cage includeapplying the graft material in the path of the cage, restricting andlimiting the biologic material dispersed within the disc space, andrequiring that the fusion cage be pushed back into the same place thatthe fusion material delivery device was, which can lead to additionaltrauma to the delicate nerve structures.

Fusion cages provide a space for inserting a bone graft between adjacentportions of bone. Such cages are often made of titanium and are hollow,threaded, and porous in order to allow a bone graft contained within theinterior of the cage of grow through the cage into adjacent vertebralbodies. Such cages are used to treat a variety of spinal disorders,including degenerative disc diseases such as Grade I or IIspondylolistheses of the lumbar spine.

Surgically implantable intervertebral fusion cages are well known in theart and have been actively used to perform spinal fusion procedures formany years. Their use became popularized during the mid-1990's with theintroduction of the BAK Device from the Zimmer Inc., a specificintervertebral fusion cage that has been implanted worldwide more thanany other intervertebral fusion cage system. The BAK system is afenestrated, threaded, cylindrical, titanium alloy device that iscapable of being implanted into a patient as described above through ananterior or posterior approach, and is indicated for cervical and lumbarspinal surgery. The BAK system typifies a spinal fusion cage in that itis a highly fenestrated, hollow structure that will fit between twovertebrae at the location of the intervertebral disc.

Spinal cages are generally inserted through a traditional openoperation, though laparoscopic or percutaneous insertion techniques mayalso be used. Cages may also be placed through a posterior lumbarinterbody fusion, or PLIF, technique, involving placement of the cagethrough a midline incision in the patient's back, or through a directlateral interbody fusion, or D-LIF, technique, involving placement ofthe cage through an incision in the patient's side.

A typical procedure for inserting a known/traditional threaded orimpacted fusion cage is as follows. First, the disc space between twovertebrae of the lumbar spine is opened using a wedge or other device ona first side of the vertebrae. The disc space is then prepared toreceive a fusion cage. Conventionally, a threaded cage is inserted intothe bore and the wedge is removed. A disc space at the first side of thevertebrae is then prepared, and a second threaded fusion cage insertedinto the bore. Alternatively, the disc space between adjacent vertebraemay simply be cleared and a cage inserted therein. Sometimes only onecage is inserted obliquely into the disc space. Use of a threaded cagemay be foregone in favor of a rectangular or pellet-shaped cage that issimply inserted into the disc space. Lastly, bone graft material may beinserted into the surgical area using separate tools and devices.

U.S. Pat. No. 4,743,256 issued to Brantigan (“Brantigan”) discloses atraditional spinal surgical method involving the implantation of aspinal fusion cage. The cage surfaces are shaped to fit within preparedendplates of the vertebrae to integrate the implant with the vertebraeand to provide a permanent load-bearing strut for maintaining the discspace. Brantigan teaches that these cages typically consist of ahomogeneous nonresorbable material such as carbon-reinforced polymerssuch as polyether ether ketone (PEEK) or polyether ketone ether ketone(“PEKEKK”). Although these cages have demonstrated an ability tofacilitate fusion, a sufficient fusion is sometimes not achieved betweenthe bone chips housed within the cage and the vertebral endplates. Inparticular, achieving a complete fusion in the middle portion of thecage has been particularly problematic. In any case, Brantigan teachesthe separate process and procedure for the insertion of a fusion cageand the insertion of bone graft. Indeed, local bone graft harvested fromthe channel cuts into the vertebrae to receive the plug supplements thefusion.

U.S. Pat. Appl. Pub. 2007/0043442 of Abernathie et al. (“Abernathie”)discloses another traditional spinal surgical method involving theimplantation of a spinal fusion cage. Abernathie relates generally to animplantable device for promoting the fusion of adjacent bony structures,and a method of using the same. More specifically, Abernathie relates toan expandable fusion cage that may be inserted into an intervertebralspace, and a method of using the same. Abernathie includes an aperturein the fusion cage to allow bone growth therethrough, as a separateprocedure to the insertion of the fusion cage.

Traditional fusion cages are available in a variety of designs andcomposed of a variety of materials. The cages or plugs are commonly madeof an inert metal substrate such as stainless steel,cobalt-chromium-molybdenum alloys, titanium or the like having a porouscoating of metal particles of similar substrate metal, preferablytitanium or the like as disclosed, for example, in the Robert M. PilliarU.S. Pat. No. 3,855,638 issued Dec. 24, 1974 and U.S. Pat. No. 4,206,516issued Jun. 10, 1980. These plugs may take the form of flat sidedcubical or rectangular slabs, cylindrical rods, cruciform blocks, andthe like.

U.S. Pat. No. 5,906,616 issued to Pavlov et al. (“Pavlov”) discloses afusion cage of various cylindrical and conical shapes and a method ofinsertion. Like Brantigan, Pavlov teaches the separate process andprocedure for the insertion of a fusion cage and the insertion of bonegraft. U.S. Pat. No. 5,702,449 (“McKay”) discloses a spinal implantcomprising a cage made of a porous biocompatible material reinforced byan outer sleeve made of a second material which is relatively strongerunder the compressive load of the spine than the biocompatible material.U.S. Pat. No. 6,569,201 issued to Moumene et al. (“Moumene”) teaches abone fusion device having a structural bioresorbable layer disposed uponthe outer surface of a non-resorbable support. As the bioresorbablestructural layer resorbs over time, the load upon the bone graft housedwithin the non-resorbable support increases. Published PCT ApplicationNo. WO 99/08627 (“Gresser”) discloses a fully bioresorbable interbodyfusion device, as well as homogeneous composite devices containing atleast 25% resorbable materials. U.S. Pat. No. 7,867,277 issued to Tohmehdiscloses a spinal fusion implant of bullet shaped end.

U.S. Pat. No. 7,846,210 issued to Perez-Cruet et al. (“Perez-Cruet”)discloses an interbody device assembly consisting of a fusion device andan insertion device. The insertion device positions the fusion devicebetween two vertebrae, provides bone graft material, and then detachesfrom the fusion device, leaving the fusion device in place to restoredisc space height. However, the Perez-Cruet device is designed toreceive bone graft material from its insertion device and distribute thematerial away from the fusion device. In most embodiments of the fusiondevice, a center plate is positioned immediately downstream of thereceived bone graft material and directs the bone graft to opposingsides of the fusion device. (See, for example, FIG. 20 depicting plate308 directing bone graft material 392 along the exterior sides of thefusion device 302). As such, the Perez-Cruet fusion device is unlikelyto completely fill the areas near of its fusion cage and deliver bonegraft material to the surrounding bone graft site. Furthermore, none ofthe Perez-Cruet fusion device embodiments feature a defined interiorspace or a cage-style design. Indeed, the Perez-Cruet fusion deviceexplicitly teaches away from a contained-interior, fusion-cage-styledevice, asserting that its fusion device fills all of the disc space asopposed to a cage design, which contains the bone material. Furthermore,the Perez-Cruet does not feature a distal tip that functions toprecisely position the fusion device and stabilize the device duringdelivery of bone graft material.

U.S. Pat. No. 7,985,256 issued to Grotz et al. (“Grotz”) discloses anexpandable spinal implant for insertion between opposed vertebral endplates. The implant is a cylinder block of slave cylinders; a centralcavity between the cylinders receives bone graft material and pistonspositioned within the cylinders provide a corrective bone engagingsurface for expanding against a first vertebral end plate. The insertiontool used to place the spinal implant includes a handle and hollowinterior for housing hydraulic control lines and a bone graft supplyline. The Grotz system does not allow precise positioning or delivery ofbone graft material without an implant and requires a complex and bulkyinsertion tool.

U.S. Pat. Appl. Pub. 2010/0198140 to Lawson (“Lawson”) discloses a toolcomprising a cannula with an open slot at the distal end and a closedtip. Lawson's tool employs tamps to push bone aside and open up a voidfor filling; solid bone pellets are then rammed down the hollow interiorof the cannula by a tamper and delivered to the surgical site. Lawsondoes not allow precise positioning or delivery of viscous bone graftmaterial and has no capability to interconnect or integrate with animplant such as a bone graft fusion cage.

U.S. Pat. Appl. Pub. 2010/0262245 to Alfaro et al. (“Alfaro”) disclosesa delivery system for an intervertebral spacer and a bone graftingmaterial comprising a spacer disengagingly attached to a hollow handle.The handle comprises a chamber and bone grafting material-advancingmeans for introducing bone grafting material from the chamber into thespacer and the intervertebral spaces. The Alfaro system does not allowprecise positioning or delivery of bone graft material through a distaltip that precisely positions the fusion device and stabilizes the deviceduring delivery of bone graft material, and does not allow primarilylateral injection of bone graft fusion material.

By way of providing additional background and context, and while knownto those skilled in the art, the following references are nonethelessidentified to help explain the nature of the surgical procedures inwhich bone graft is used and to further describe the various tools andother apparatus commonly associated therewith: U.S. Pat. No. 6,309,395to Smith et al.; U.S. Pat. No. 6,142,998 to Smith et al.; U.S. Pat. No.7,014,640 to Kemppanien et al.; U.S. Pat. No. 7,406,775 to Funk, et al.;U.S. Pat. No. 7,387,643 to Michelson; U.S. Pat. No. 7,341,590 to Ferree;U.S. Pat. No. 7,288,093 to Michelson; U.S. Pat. No. 7,207,992 toRitland; U.S. Pat. No. 7,077,864 Byrd III, et al.; U.S. Pat. No.7,025,769 to Ferree; U.S. Pat. No. 6,719,795 to Cornwall, et al.; U.S.Pat. No. 6,364,880 to Michelson; U.S. Pat. No. 6,328,738 to Suddaby;U.S. Pat. No. 6,290,724 to Marino; U.S. Pat. No. 6,113,602 to Sand; U.S.Pat. No. 6,030,401 to Marino; U.S. Pat. No. 5,865,846 to Bryan, et al.;U.S. Pat. No. 5,569,246 to Ojima, et al.; U.S. Pat. No. 5,527,312 toRay; and U.S. Pat. Appl. Pub. No. 2008/0255564 to Michelson.

By way of providing additional background and context, and while knownto those skilled in the art, the following references are nonethelessidentified to help explain the nature of the surgical procedures inwhich fusion cages are used and to further describe the various toolsand other apparatus commonly associated therewith: U.S. Pat. No.6,569,201 to Moumene et al.; U.S. Pat. No. 6,159,211 to Boriani et al.;U.S. Pat. No. 4,743,256 to Brantigan; U.S. Pat. Appl. 2007/0043442 toAbernathie et al.; U.S. Pat. Nos. 3,855,638 and 4,206,516 to Pilliar;U.S. Pat. No. 5,906,616 issued to Pavlov et al.; U.S. Pat. No. 5,702,449to McKay; U.S. Pat. No. 6,569,201 to Moumene et al.; PCT Appl. No. WO99/08627 to Gresser; U.S. Pat. Appl. Pub. 2012/0022651 to Akyuz et al.;U.S. Pat. Appl. Pub. 2011/0015748 to Molz et al.; U.S. Pat. Appl. Pub.2010/0249934 to Melkent; U.S. Pat. Appl. Pub. 2009/0187194 to Hamada;U.S. Pat. No. 7,867,277 issued to Tohmeh; U.S. Pat. No. 7,846,210 toPerez-Cruet et al.; U.S. Pat. No. 7,985,256 issued to Grotz et al.; U.S.Pat. Appl. Pub. 2010/0198140 to Lawson; and U.S. Pat. Appl. Pub.2010/0262245 to Alfaro et al.

By way of providing additional background and context, and while knownto those skilled in the art, the following references are nonethelessidentified to help explain the nature of spinal fusion and devices andmethods commonly associated therewith: U.S. Pat. No. 7,595,043 issued toHedrick et al.; U.S. Pat. No. 6,890,728 to Dolecek et al.; U.S. Pat. No.7,364,657 to Mandrusov, and U.S. Pat. No. 8,088,163 to Kleiner.

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No. 7,897,564 entitled“Flowable Carrier Matrix and Methods for Delivering to a Patient” toBeals et al., issued Mar. 1, 2011; U.S. Pat. Appl. Pub. No. 2011/0160777entitled “System and Methods of Maintaining Space for Augmentation ofthe Alveolar Ridge” to Spagnoli et al., issued Jun. 30, 2011; U.S. Pat.Appl. Pub. No. 2009/0246244 entitled “Malleable Multi-Component Implantsand Materials Therefor” to McKay et al., issued Oct. 1, 2009; U.S. Pat.Appl. Pub. No. 2009/0246244 entitled “Malleable Multi-Component Implantsand Materials Therefor” to McKay et al., issued Oct. 1, 2009; U.S. Pat.Appl. Pub. No. 2013/0110169 entitled “Vertebral Rod System and Methodsof Use” to Hynes, et al., issued May 2, 2013; U.S. Pat. Appl. Pub. No.2011/0184412 entitled “Pre-Assembled Construct With One Or MoreNon-Rotating Connectors For Insertion Into a Patient” to Scifert, etal., issued Jul. 28, 2011; U.S. Pat. No. 7,964,208 entitled “System andMethods of Maintaining Space For Augmentation of the Alveolar Ridge” toSpagnoli, et al., issued Jun. 21, 2011; U.S. Pat. No. 8,080,521 entitled“Flowable Carrier Matrix and Methods for Delivering to a Patient” toBeals, et al., issued Dec. 20, 2011; U.S. Pat. Appl. Pub. No.2009/0142385 entitled “Compositions for Treating Bone Defects” to Gross,et al., issued Jun. 4, 2009; U.S. Pat. No. 7,578,820 entitled “Devicesand Techniques for a Minimally Invasive Disc Space Preparation andImplant Insertion” to Moore, et al., issued Aug. 25, 2009; U.S. Pat.Appl. Pub. No. 2010/0305575 entitled “Methods and Apparatus forPerforming Knee Arthroplasty” to Wilkinson, et al., issued Dec. 2, 2010;U.S. Pat. Appl. Pub. No. 2011/0021427 entitled “Biphasic CalciumPhosphate Cement for Drug Delivery” to Amsden, et al., issued Jan. 27,2011; U.S. Pat. Appl. Pub. No. 2012/0259335 entitled “Patello-FemoralJoint Implant and Instrumentation” to Scifert, et al., issued Oct. 11,2012; U.S. Pat. Appl. No. 2011/0106162 entitled “Composite ConnectingElements for Spinal Stabilization Systems” to Ballard, et al., issuedMay 5, 2011; U.S. Pat. Appl. No. 2004/0073314 entitled “Vertebral Bodyand Disc Space Replacement Devices” to White, et al., issued Apr. 15,2004; U.S. Pat. No. 7,513,901 entitled “Graft Syringe Assembly” toScifert, et al., issued Apr. 7, 2009; U.S. Pat. Appl. No. 2010/0004752entitled “Vertebral Body and Disc Space Replacement Devices” to White,et al., issued Jan. 7, 2010; U.S. Pat. No. 7,615,078 entitled “VertebralBody and Disc Space Replacement Devices” to White, et al., issued Nov.10, 2009; U.S. Pat. No. 6,991,653 entitled “Vertebral Body and DiscSpace Replacement Devices” to White, et al., issued Jan. 31, 2006; U.S.Pat. Appl. Pub. No. 2010/0331847 entitled “Methods and Apparatus forPerforming Knee Arthroplasty” to Wilkinson, et al., issued Dec. 30,2010; U.S. Pat. Appl. Pub. No. 2006/0116770 entitled “Vertebral Body andDisc Space Replacement Devices” to White, et al., issued Jun. 1, 2006;and U.S. Pat. No. 8,246,572 entitled “Bone Graft Applicator” to Cantor,et al., issued Aug. 21, 2012.

The prior art bone graft delivery devices listed above typically mustcome pre-loaded with bone graft, or alternatively require constantloading (where permissible) in order to constantly have the desiredsupply of bone graft available. Moreover, these bone graft deliverydevices generally cannot handle particulate bone graft of varying orirregular particulate size. Furthermore, the prior art devices forinserting a fusion cage or other medical implant into a patient's spineor other surgical area are commonly distinct and separate fromtraditional devices that deliver bone graft material to the surgicalsite. As such, two devices are traditionally used to insert bone graftmaterial into a patient's spine and to position and insert a fusioncage. The problems associated with separate administration of thebiologic material bone graft material and the insertion of a fusion cageinclude applying the graft material in the path of the cage, restrictingand limiting the biologic material dispersed within the disk space, andrequiring that the fusion cage be pushed back into the same place thatthe fusion material delivery device was, which can lead to additionaltrauma to the delicate nerve structures. These problems can be a greatinconvenience, cause avoidable trauma to a patient and make these priorart devices unsuitable in many procedures.

Therefore, there is a long-felt need for an apparatus and method forprecision delivery of bone graft material into a surgical location suchas a patient's spine that does not include the deficiencies of prior artdevices. The present invention solves these needs.

SUMMARY OF THE INVENTION

Certain embodiments of the present disclosure relate to an apparatus andmethod for near-simultaneous and integrated delivery of bone graftmaterial during the placement of surgical cages or other medicalimplants in a patient's spine. The integrated fusion cage and deliverydevice (the “device”) is comprised generally of a tubular member and aplunger for expelling bone graft from the tubular member, through asurgical fusion cage, and into a bone graft receiving area, thendisengaging the fusion cage at the surgical site in a human patient.Thus, the apparatus and method allow the biologic material to flowdirectly into and through the fusion cage and to be dispersed within thedisc space in a single step, and to position the detachable fusion cagein the surgical area. In one embodiment, the integrated fusion cage isan expandable integrated fusion cage. Other embodiments and alternativesto this device are described in greater detail below.

It is one aspect of the present invention to provide a bone graftmaterial delivery system, comprising an elongate hollow tube configuredto receive bone graft material, the elongate hollow tube having alongitudinal axis, an open proximal end, a distal end, and a firstopening at the distal end; a plunger adapted to extend in the elongatehollow tube, the plunger having a shaft and a distal portion, whereinthe plunger is configured to urge the bone graft material through theelongate hollow tube; and a first injection device configured to containthe bone graft material therein and to connect to the open proximal endof the elongate hollow tube, whereby the bone graft material may bedischarged from the first injection device into the elongate hollowtube.

It is another aspect of the present invention to provide a bone graftmaterial delivery system, comprising: an elongate hollow tube configuredto receive bone graft material, the elongate hollow tube having alongitudinal axis, an open proximal end, a distal end, and a firstopening at the distal end; a plunger adapted to extend in the elongatehollow tube, the plunger having a shaft and a distal portion, whereinthe plunger is configured to urge the bone graft material through theelongate hollow tube; a first syringe containing the bone graft materialtherein and configured to connect to the open proximal end of theelongate hollow tube, whereby the bone graft material may be dischargedfrom the first syringe into the elongate hollow tube; and an implantconfigured to attach to the distal end of the elongate hollow tube andallow the bone graft material to pass through it.

It is another aspect of the present invention to provide a bone graftdelivery device, comprising an elongate tube including a first sideopposite to a second side, the first and second sides connected byopposing third and fourth sides such that the elongate tube has a hollowinterior with a generally rectangular cross-section, wherein theelongate tube includes a proximal end, at least one opening to dischargebone graft, and a distal end that is wedge-shaped, wherein the distalend is at least partially closed; a plunger with a distal portion and ashaft, the distal portion configured to urge the bone graft through thehollow interior of the elongate tube, the shaft being generally linearand having a plurality of teeth; and actuating means for applying aforce to the plunger to advance the plunger within the elongate tubetoward the distal end such that bone graft is delivered through theopening into a surgical site.

In various embodiments, the actuating means may include an actuatorconfigured to engage the plurality of teeth of the plunger shaft.

In various embodiments, the actuating means may include a gearconfigured to engage the plurality of teeth of the plunger shaft toconvert rotational motion of the gear into linear movement of theplunger.

In various embodiments, the at least one opening may include an openingformed through one of the first, second, third, and fourth sides.

In various embodiments, the hollow tube may be generally linear and maybe rigid.

In another embodiment of the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by way of a Luer taperor Luer fitting connection, such as in a Luer-Lok or Luer-Slipxconfiguration or any other Luer taper or Luer fitting connectionconfiguration. For purposes of illustration, and without wishing to beheld to any one embodiment, the following U.S. Patent Application isincorporated herein by reference in order to provide an illustrative andenabling disclosure and general description of means to selectablydetach the fusion cage of the integrated fusion cage and graft deliverydevice: U.S. Patent Appl. No. 2009/0124980 to Chen.

In another embodiment of the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by way of a pedicledart by threadable rotation to achieve attachment, detachment, and axialmovement. Other ways include a quick key insertion, an external snapdetent, or magnetic attraction or any other structure. For purposes ofillustration, and without wishing to be held to any one embodiment, thefollowing U.S. Patent Application is incorporated herein by reference inorder to provide an illustrative and enabling disclosure and generaldescription of means to selectably detach the fusion cage of theintegrated fusion cage and graft delivery device: U.S. Patent Appl. No.2009/0187194 to Hamada.

In another embodiment of the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by use of magnetism.More specifically, the detachable fusion cage can be made to feature amagnetic field pattern and a resulting force R that are adjustable andmay be of different character than the rest of the integrated fusioncage and graft delivery device. With permanent magnets, such adjustmentscan be made mechanically by orienting various permanent magnet polargeometries and corresponding shapes relative to one another. U.S. Pat.No. 5,595,563 to Moisdon describes further background regarding suchadjustment techniques, which is hereby incorporated by reference in itsentirety. Alternatively, or additionally, electromagnets could be usedin combination with permanent magnets to provide adjustability. Infurther embodiments, the magnets and corresponding fields and theresultant magnetic field pattern can include both attraction forces fromplacement of opposite pole types in proximity to one another andrepulsion forces from placement of like pole types in proximity to oneanother. As used herein, “repulsive magnetic force” or “repulsive force”refers to a force resulting from the placement of like magnetic poles inproximity to one another either with or without attractive forces alsobeing present due to opposite magnetic poles being placed in proximityto one another, and further refers to any one of such forces whenmultiple instances are present. U.S. Pat. No. 6,387,096 is cited as asource of additional information concerning repulsive forces that areprovided together with attractive magnetic forces, which is herebyincorporated by reference. In another alternative embodiment example,one or more of surfaces of the fusion cage are roughened or otherwiseinclude bone-engaging structures to secure purchase with vertebralsurfaces. In yet other embodiments, the selectable detachable featurebetween the detachable fusion cage and the integrated fusion cage andgraft delivery device can include one or more tethers, cables, braids,wires, cords, bands, filaments, fibers, and/or sheets; a nonfabric tubecomprised of an organic polymer, metal, and/or composite; an accordionor bellows tube type that may or may not include a fabric, filamentous,fibrous, and/or woven structure; a combination of these, or suchdifferent arrangement as would occur to one skilled in the art.Alternatively or additionally, the selectable detachable feature betweenthe detachable fusion cage and the integrated fusion cage and graftdelivery device can be arranged to present one or more openings betweenmembers or portions, where such openings extend between end portions ofthe fusion cage. For purposes of illustration, and without wishing to beheld to any one embodiment, the following U.S. Patent Application isincorporated herein by reference in order to provide an illustrative andenabling disclosure and general description of means to selectablydetach the fusion cage of the integrated fusion cage and graft deliverydevice: U.S. Patent Appl. No. 2011/0015748 to Molz et al.

In another embodiment of the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by use of plasmatreatment. The term “plasma” in this context is an ionized gascontaining excited species such as ions, radicals, electrons andphotons. (Lunk and Schmid, Contrib. Plasma Phys., 28: 275 (1998)). Theterm “plasma treatment” refers to a protocol in which a surface ismodified using a plasma generated from process gases including, but notlimited to, O₂, He, N₂, Ar and N₂O. To excite the plasma, energy isapplied to the system through electrodes. This power may be alternatingcurrent (AC), direct current (DC), radiofrequency (RF), or microwavefrequency (MW). The plasma may be generated in a vacuum or atatmospheric pressure. The plasma can also be used to deposit polymeric,ceramic or metallic thin films onto surfaces (Ratner, Ultrathin Films(by Plasma deposition), 11 Polymeric Materials Encyclopedia 8444-8451,(1996)). Plasma treatment is an effective method to uniformly alter thesurface properties of substrates having different or unique size, shapeand geometry including but not limited to bone and bone compositematerials. Plasma Treatment may be employed to effect magneticproperties on elements of the integrated fusion cage and graft deliverydevice, or to provide selectable detachment of the fusion cage. Forpurposes of illustration, and without wishing to be held to any oneembodiment, the following U.S. Patent is incorporated herein byreference in order to provide an illustrative and enabling disclosureand general description of means to selectably detach the fusion cage ofthe integrated fusion cage and graft delivery device: U.S. Pat. No.7,749,555 to Zanella et al.

In one embodiment, the device is not a caulking gun style device, thatis the bone graft material and/or the fusion cage are not deliveredand/or positioned using a hand-pump and/or hand-squeeze mechanism.Instead, the device delivers graft material and/or a fusion cage using ahollow tube and plunger arrangement which is not a caulking gun styledevice and further, does not appreciably disrupt or block the user'sview of the surgical site and/or enable precision delivery of bone graftmaterial and/or a fusion cage to the surgical site. Indeed, the deviceof one embodiment of the present disclosure is distinctly unlike thecaulking gun device of U.S. Pat. Appl. No. 2004/0215201 to Lieberman(“Lieberman”), which requires an L-shaped base member handle, rack teethto advance a plunger member, and user action on a lever of the L-shapedbase member handle to deploy bone graft material. In one embodiment, thedevice of this application is not a caulking gun style device and doesnot comprise rack teeth, a base member handle and at least one componentthat obscures user viewing of the surgical site. Lieberman isincorporated by reference in its entirety for all purposes.

Similarly, in one embodiment, the device is distinctly unlike thecaulking gun device of U.S. Pat. Appl. No. 2002/0049448 to Sand et al(“Sand”), which requires a gun and trigger mechanism in which the usersqueezes together a gun-style handle to deploy material into bone. TheSand device obstructs the view of the user of the delivery site. In oneembodiment, the device of this application is not a caulking gun styledevice and does not comprise an opposing-levered, gun-style deliverymechanism and at least one component that obscures user viewing of thesurgical site. Sand is incorporated by reference in its entirety for allpurposes.

Other caulking gun type devices are described in U.S. Pat. Nos.8,932,295 and 9,655,748 which are each incorporated herein by referencein their entirety.

However, while in some embodiments the bone graft delivery device of thepresent invention may not be a caulking gun-style device, it is to beexpressly understood that caulking gun-type designs are within the scopeof the present invention, and indeed may even be desirable in certainembodiments and applications. By way of non-limiting example, it may beadvantageous to provide a caulking gun-type mechanism for the purpose ofmaking it easier for a user to apply pressure against a plunger tofacilitate controlled movement of the plunger and/or a hollow tuberelative to the plunger. A handle and pivotally mounted trigger attachedto a ratchet-type push bar, as are commonly associated with caulkingguns and similar devices, may be provided, in these and otherembodiments, instead of or in addition to a rack-and-pinion-type linearactuator.

In one embodiment, the device is configured to deliver bone graftmaterial substantially laterally from its delivery end, that issubstantially not in the axial direction but rather substantially fromthe side and/or in a radial direction. This is distinctly different thandevices that deliver bone graft material along their vertical axis, thatis, along or out their bottom end, and/or obstruct the user view of thebone graft and/or fusion cage delivery site, such as that of U.S. Pat.Appl. No. 2010/0087828 to Krueger et al (“Krueger”), U.S. Pat. Appl. No.2009/0264892 to Beyar et al (“Beyar”), U.S. Pat. Appl. No. 2007/0185496to Beckman et al (“Beckman”), U.S. Pat. Appl. No. 2009/0275995 toTruckai et al (“Truckai”) and U.S. Pat. Appl. No. 2006/0264964 toSeifert et al (“Seifert”). Krueger, Beyar, Beckman, Truckai and Seifertare incorporated by reference in their entireties for all purposes.

In one embodiment, the device is configured to deliver bone graftmaterial so as to completely fill the defined interior of its fusioncage and subsequently deliver bone graft material to the surroundingbone graft site, rather than, for example, to contain the bone materialas are the fusion cage designs of U.S. Pat. No. 7,846,210 to Perez-Cruet(“Perez-Cruet”). Further, the fusion device of this application featuresa distal tip that functions to precisely position the fusion device andstabilize the device during delivery of bone graft material. Perez-Cruetis incorporated by reference in its entirety for all purposes.

In addition, by way of providing additional background and context, thefollowing references are also incorporated by reference in theirentireties for the purpose of explaining the nature of spinal fusion anddevices and methods commonly associated therewith, to include, withoutlimitation, expandable fusion cages: U.S. Pat. No. 4,863,476 toShepperd; U.S. Pat. No. 6,743,255 to Ferree; U.S. Pat. No. 6,773,460 toJackson; U.S. Pat. No. 6,835,206 to Jackson; U.S. Pat. No. 6,972,035 toMichelson; U.S. Pat. No. 7,771,473 to Thramann; U.S. Pat. No. 7,850,733to Baynham; U.S. Pat. No. 8,506,635 to Palmatier; U.S. Pat. No.8,556,979 to Glerum; U.S. Pat. No. 8,628,576 to Triplett; U.S. Pat. No.8,709,086 to Glerum; U.S. Pat. No. 8,715,351 to Pinto; U.S. Pat. No.8,753,347 to McCormack; U.S. Pat. No. 8,753,377 to McCormack; U.S.Design Patent No. D708,323 to Reyes; U.S. Pat. No. 8,771,360 to Jimenez;U.S. Pat. No. 8,778,025 to Ragab; U.S. Pat. No. 8,778,027 to Medina;U.S. Pat. No. 8,808,383 to Kwak; U.S. Pat. No. 8,814,940 to Curran; U.S.Pat. No. 8,821,396 to Miles; U.S. Patent Application Publication No.2006/0142858 to Colleran; U.S. Patent Application Publication No.2008/0086142 to Kohm; U.S. Patent Application Publication No.2010/0286779 to Thibodean; U.S. Patent Application Publication No.2011/0301712 to Palmatier; U.S. Patent Application Publication No.2012/0022603 to Kirschman; U.S. Patent Application Publication No.2012/0035729 to Glerum; U.S. Patent Application Publication No.2012/0089185 to Gabelberger; U.S. Patent Application Publication No.2012/0123546 to Medina; U.S. Patent Application Publication No.2012/0197311 to Kirschman; U.S. Patent Application Publication No.2012/0215316 to Mohr; U.S. Patent Application Publication No.2013/0158664 to Palmatier; U.S. Patent Application Publication No.2013/0178940; U.S. Patent Application Publication No. 2014/0012383 toTriplett; U.S. Patent Application Publication No. 2014/0156006; U.S.Patent Application Publication No. 2014/0172103 to O'Neil; U.S. PatentApplication Publication No. 2014/0172106 to; U.S. Patent ApplicationPublication No. 2014/0207239 to Barreiro; U.S. Patent ApplicationPublication No. 2014/0228955 to Weiman; U.S. Patent ApplicationPublication No. 2014/0236296 to Wagner; U.S. Patent ApplicationPublication No. 2014/0236297 to Iott; U.S. Patent ApplicationPublication No. 2014/0236298 to Pinto.

Furthermore, by way of providing additional background and context, thefollowing references are also incorporated by reference in theirentireties for the purpose of explaining the nature of spinal fusion anddevices and methods commonly associated therewith, to include, withoutlimitation, expandable fusion cages: U.S. Pat. No. 7,803,159 toPerez-Cruet et al.; U.S. Pat. No. 8,852,282 to Farley et al.; U.S. Pat.No. 8,858,598 to Seifert et al.; U.S. Patent No. D714,933 to Kawamura;U.S. Pat. No. 8,795,366 to Varela; U.S. Pat. No. 8,852,244 to Simonson;U.S. Patent Application Publication No. 2012/0158146 to Glerum et al.;U.S. Pat. No. 8,852,242 to Morgenstern Lopez et al.; U.S. Pat. No.8,852,281 to Phelps; U.S. Pat. No. 8,840,668 to Donahoe et al.; U.S.Pat. No. 8,840,622 to Vellido et al.; U.S. Patent ApplicationPublication No. 2014/0257405; U.S. Patent Application Publication No.2014/0257490 to Himmelberger et al.; U.S. Pat. No. 8,828,019 to Raymondet al.; U.S. Patent Application Publication No. 2014/0288652 to Boehm etal.; U.S. Patent Application Publication No. 2014/0287055 to Kunjachan;U.S. Patent Application Publication No. 2014/0276896 to Harper; U.S.Patent Application Publication No. 2014/0277497 to Bennett et al.; U.S.Patent Application Publication No. 2012/0029635 to Schoenhoeffer et al.;U.S. Patent Application Publication No. 2014/0303675 to Mishra; U.S.Patent Application Publication No. 2014/0303731 to Glerum; U.S. PatentApplication Publication No. 2014/0303732 to Rhoda et al.; U.S. Pat. No.8,852,279 to Weiman; PCT Pub. WO 2012/031267 to Weiman; U.S. Pat. No.8,845,731 to Weiman; U.S. Pat. No. 8,845,732 to Weiman; U.S. Pat. No.8,845,734 to Weiman; U.S. Patent Application Publication No.2014/0296985 to Balasubramanian et al.; U.S. Patent ApplicationPublication No. 2014/0309268 to Arnou; U.S. Patent ApplicationPublication No. 2014/0309548 to Merz et al.; U.S. Patent ApplicationPublication No. 2014/0309697 to Iott et al.; U.S. Patent ApplicationPublication No. 2014/0309714 to Mercanzini et al.; U.S. Pat. No.8,282,683 to McLaughlin et al.; U.S. Pat. No. 8,591,585 to McLaughlin etal; U.S. Pat. No. 8,394,129 to Morgenstern Lopez et al.; U.S. PatentApplication Publication No. 2011/0208226 to Fatone et al.; U.S. PatentApplication Publication No. 2010/0114147 to Biyani; U.S. PatentApplication Publication No. 2011/0144687 to Kleiner; U.S. Pat. No.8,852,243 to Morgenstern Lopez et al.; U.S. Pat. No. 8,597,333 toMorgenstern Lopez et al.; U.S. Pat. No. 8,518,087 to Lopez et al.; U.S.Patent Application Publication No. 2012/0071981 to Farley et al.; U.S.Patent Application Publication No. 2013/0006366 to Farley et al.; U.S.Patent Application Publication No. 2012/0065613 to Pepper et al.; U.S.Patent Application Publication No. 2013/0006365 to Pepper et al.; U.S.Patent Application Publication No. 2011/0257478 to Kleiner et al.; U.S.Patent Application Publication No. 2009/0182429 to Humphreys et al.;U.S. Patent Application Publication No. 2005/0118550 to Turri; U.S.Patent Application Publication No. 2009/0292361 to Lopez; U.S. PatentApplication Publication No. 2011/0054538 to Zehavi et al.; U.S. PatentApplication Publication No. 2005/0080443 to Fallin et al.; U.S. Pat. No.8,778,025 to Ragab et al.; U.S. Pat. No. 8,628,576 to Triplett et al;U.S. Pat. No. 8,808,304 to Weiman, and U.S. Pat. No. 8,828,019 toRaymond.

All of the following U.S. Patents are also incorporated herein byreference in their entirety: U.S. Pat. Nos. 6,595,998; 6,997,929;7,311,713; 7,749,255; 7,753,912; 7,780,734; 7,799,034; 7,875,078;7,931,688; 7,967,867; 8,075,623; 8,123,755; 8,142,437; 8,162,990;8,167,887; 8,197,544; 8,202,274; 8,206,395; 8,206,398; 8,317,802;8,337,531; 8,337,532; 8,337,562; 8,343,193; 8,349,014; 8,372,120;8,394,108; 8,414,622; 8,430,885; 8,439,929; 8,454,664; 8,475,500;8,512,383; 8,523,906; 8,529,627; 8,535,353; 8,562,654; 8,574,299;8,641,739; 8,657,826; 8,663,281; 8,715,351; 8,727,975; 8,828,019;8,845,640; 8,864,830; 8,900,313; 8,920,507; 8,974,464; 9,039,767;9,084,686; 9,095,446; 9,095,447; 9,101,488; 9,107,766; 9,113,962;9,114,026; 9,149,302; 9,174,147; 9,216,094; 9,226,777; 9,295,500;9,358,134; 9,381,094; 9,439,692; 9,439,783; 9,445,921; 9,456,830;9,480,578; 9,498,200; 9,498,347; 9,498,351; 9,517,140; 9,517,141;9,517,142; 9,545,250; 9,545,279; 9,545,313; 9,545,318; 9,610,175;9,629,668; 9,655,660; 9,655,743; 9,681,889; 9,687,360; 9,707,094;9,763,700; 9,861,395; 9,980,737; 9,993,353; U.S. Pat. Pub. 2014/0088712;U.S. Pat. Pub. 2014/0276581; U.S. Pat. Pub. 2014/0371721; U.S. Pat. Pub.2016/0296344; U.S. Pat. Pub. 2017/0367846; U.S. Pat. Pub. 2017/0354514.

This Summary of the Invention is neither intended nor should it beconstrued as being representative of the full extent and scope of thepresent disclosure. The present disclosure is set forth in variouslevels of detail in the Summary of the Invention as well as in theattached drawings and the Detailed Description, and no limitation as tothe scope of the present disclosure is intended by either the inclusionor non-inclusion of elements, components, etc. in this Summary of theInvention. Additional aspects of the present disclosure will become morereadily apparent from the Detailed Description, particularly when takentogether with the drawings.

The above-described benefits, embodiments, and/or characterizations arenot necessarily complete or exhaustive, and in particular, as to thepatentable subject matter disclosed herein. Other benefits, embodiments,and/or characterizations of the present disclosure are possibleutilizing, alone or in combination, as set forth above and/or describedin the accompanying figures and/or in the description herein below.However, the Detailed Description, the drawing figures, and theexemplary claim set forth herein, taken in conjunction with this Summaryof the Invention, define the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the disclosure andtogether with the general description of the disclosure given above andthe detailed description of the drawings given below, serve to explainthe principles of the disclosures.

It should be understood that the drawings are not necessarily to scale.In certain instances, details that are not necessary for anunderstanding of the disclosure or that render other details difficultto perceive may have been omitted. It should be understood, of course,that the disclosure is not necessarily limited to the particularembodiments illustrated herein.

FIG. 1A is a front perspective view of a hollow tubular member of thedevice for delivering bone graft according to one embodiment of thepresent invention;

FIG. 1B is a front perspective view of the plunger of the device;

FIG. 1C is a cross sectional view of a portion of the device shown inFIG. 1A;

FIG. 2 is a front perspective view of one embodiment of the device,showing the relationship between the tubular and plunger portions wherethe tubular portion includes two lateral facing openings at the distalend of the tubular portion and a wedge-shaped distal end of the tubularmember;

FIG. 3 is another front perspective view of the tubular portion of thedevice of FIG. 2 showing the second of two lateral openings at thedistal end of the tubular portion and a wedge-shaped distal end of thetubular member;

FIG. 4 is a front elevation view of the distal end of the tubularportion of the device of FIG. 2;

FIG. 5 is a bottom elevation view of the proximal end of the tubulardevice of FIG. 2;

FIG. 6A is a top plan view of the device of FIG. 2 with the plungerportion fully inserted into the tubular portion;

FIG. 6B is a left elevation view of the device of FIG. 2 with theplunger portion fully inserted into the tubular portion;

FIG. 6C is a bottom plan view of the device of FIG. 2 with the plungerportion fully inserted into the tubular portion;

FIG. 6D is a right elevation view of the device of FIG. 2 with theplunger portion fully inserted into the tubular portion;

FIG. 7A is a perspective view of a device for delivering bone graft ofanother embodiment illustrating a hollow tubular member including aplurality of vent ports and a plunger of an embodiment of the presentdisclosure;

FIG. 7B is a top plan view of the hollow tubular member of FIG. 7A and adetachable funnel;

FIG. 7C is a side elevation view of the hollow tubular member of FIG. 7Ainterconnected to the funnel and including a plunger inserted into alumen of the hollow tubular member;

FIG. 7D is a front elevation view of the hollow tubular member of FIG.7A and illustrating an optional opening at the distal end;

FIG. 7E is an expanded cross-sectional view of a portion of the hollowtubular member;

FIG. 7F illustrates devices used to prepare bone graft materialaccording to one embodiment of the present disclosure;

FIG. 7G is an environmental view of a surgical site and a bone graftdelivery device according to one embodiment of the present disclosure;

FIG. 8 is an environmental view of an intervertebral disc space and aprior art bone graft delivery device;

FIG. 9A is an environmental view of a surgical site and a bone graftdelivery device according to one embodiment of the present disclosure;

FIG. 9B is another environmental view of the surgical site of FIG. 9Aafter the bone graft delivery device has been removed therefrom;

FIG. 10 is an exploded view of a graft delivery device of anotherembodiment of the present disclosure;

FIG. 11 is an expanded partial perspective view illustrating a distalportion of a hollow tube of the graft delivery device of FIG. 10;

FIG. 12 is a cross-sectional view of the distal portion of the hollowtube;

FIG. 13 is a perspective view of a distal portion of a plunger of thegraft delivery device of FIG. 10;

FIG. 14 is a side elevation view of the distal portion of the plunger;

FIG. 15 is a top plan view of the distal portion of the plunger;

FIG. 16 is a cross-sectional view of a distal portion of the graftdelivery device of FIG. 10 illustrating the distal end of the plunger ina first state generally parallel to a longitudinal axis of the plunger;

FIG. 17 is another cross-section view of the distal portion of the graftdelivery device illustrating the distal end of the plunger in a secondstate after bending transverse to the longitudinal axis;

FIG. 18 is and exploded view of a graft delivery device of yet anotherembodiment of the present disclosure;

FIG. 19 is an expanded partial perspective view illustrating a distalportion of a hollow tube of the graft delivery device of FIG. 18;

FIG. 20 is a cross-sectional view of the distal portion of the hollowtube;

FIG. 21 is a perspective view of a distal portion of a plunger of thegraft delivery device of FIG. 18;

FIG. 22 is a side elevation view of the distal portion of the plunger;

FIG. 23 is a top plan view of the distal portion of the plunger;

FIG. 24 is a cross-sectional view of a distal portion of the graftdelivery device of FIG. 18 illustrating arms of the distal end of theplunger in a first state generally parallel to a longitudinal axis ofthe plunger;

FIG. 25 is another cross-section view of the distal portion of the graftdelivery device illustrating the arms of the plunger in a second stateafter bending transverse to the longitudinal axis;

FIG. 26 is a top perspective view of another embodiment of a device fordelivering bone graft; and

FIG. 27 is a top perspective view of still another integrated fusioncage and graft delivery device of the present disclosure.

To provide further clarity to the Detailed Description provided hereinin the associated drawings, the following list of components andassociated numbering are provided as follows:

Reference No. Component  1 Integrated fusion cage and graft deliverydevice  2 Hollow tube  3 Hollow tube first (side) surface   3A Firstside   3B Second side  4 Opening (of Hollow tube)  5 Hollow tube second(top and bottom) surface  6 First (or proximal) end (of Hollow tube)  6A Knob   6B Pin  7 Hollow tube first distal opening  8 Second (ordistal) end (of Hollow tube)  9 Ramp   9A Ramp surface   9B Ramp surface10 Curved surface (of Hollow tube) 12 Plunger 16 Handle (of Plunger)  16A Plunger stop 17 Plunger medial portion 18 Second (or distal) end(of Plunger)   18A Pusher 19 Horizontal surface (of Plunger) 20 Curvedsurface (of Plunger) 21 Vent port 22 First portion 23 Second portion 24Joint or plane 25 Peg or pin 26 Recess 27 Teeth or notches of plunger 28Lumen 29 Indicia to indicate depth of insertion of distal end 30 Funnel32 Sleeve (of Funnel) 33 Slot for pin of bayonet mount 35 Vent channelin plunger pusher 36 Endoscope, camera, or image sensing device 37Lighting element 42 Syringe 44 Bone graft material 46 Luer lock device48 Bore 50 Wedge-shaped Second end (of Hollow tube) 52 Wedge-shapedSecond end (of Plunger) 60 Fusion Cage 64 Fusion Cage Second (or Distal)End 65 Fusion Cage First Opening Pair 70 Width of hollow tube 74 Bluntsurfaces of plunger distal end 78 Opposing surfaces of the plunger 80Area of flexibility of the plunger 82 Relief areas 84 Ends of notches 86Rabbet 88 Width of plunger 90 Gap 92 Groove   94A First arm   94B Secondarm 170  Bone graft deliver device 171  Spine 172  Surgical site 174 Path for fusion cage 304  Grip 306  Trigger 308  Handle 310  Knob 312 Switch or button 314  Loading port 316  Capsule or package of bone graftmaterial 318  Knob of grip 320  Flange 322  Slot 324  Channel 326 Proximal opening of channel A Height of Opening (in Hollow tube) B Widthof Opening (in Hollow tube)

DETAILED DESCRIPTION

The present invention relates to a system, device/apparatus and methodfor integrated and near-simultaneous delivery of bone graft material anda fusion cage to any portion of a patient which requires bone graftmaterial and/or a fusion cage. Thus, for example, the foregoingdescription of the various embodiments contemplates delivery to, forexample, a window cut in a bone, where access to such window for bonegrafting is difficult to obtain because of orientation of such window,presence of muscle tissue, risk of injury or infection, etc. Theintegrated fusion cage and graft delivery device is formed such that theone or more hollow tubes and/or plungers may be helpful in selectivelyand controllably placing bone graft material and a fusion cage in oradjacent to such window. The integrated fusion cage and graft deliverydevice is formed to allow delivery of bone graft material and/or afusion cage in a direction other than solely along the longitudinal axisof the device, and in some embodiments transverse to the primary axisused by the surgeon or operator of the device when inserting the deviceinto a cannula or other conduit to access the surgical site. This sameconcept applies to other areas of a patient, whether or not a window hasbeen cut in a bone, for example in a vertebral disc space, and may beused whether this is a first surgery to the area or a follow-up surgery.The present invention also contemplates the delivery of bone graftmaterial and/or a fusion cage with or without the use of a plunger, andwith or without the use of various other tools described in greaterdetail herein. The present invention also contemplates the delivery of aspinal fusion implant into a collapsed vertebra, and filling it withfiller material.

Referring now to FIG. 1A, an integrated fusion cage 60 and graftdelivery system, or device 1 is shown, which is comprised of a hollowtubular member or hollow tube 2 or contains at least one inner lumen,which has a first proximate end 6 (which is referred to elsewhere inthis specification as the “graspable end” of hollow tube 2), and asecond distal end 8 having an opening 7, with a general hollow structuretherebetween. Thus, as shown in FIG. 1, the hollow tube 2 allows bonegraft material to be inserted into the opening 4 at the graspable end 6of the hollow tube 2, and ultimately exited from the hollow tube 2through the opening 7 of the distal end 8. According to a preferredembodiment, the hollow tube 2 also comprises at least one sloped orcurved surface 10 at or near the distal end 8 of the hollow tube 2.Although the distal end 8 and its opening 7 are shown as having agenerally rectangular cross-section, the cross-section need not belimited to a generally rectangular shape. For example, in variousembodiments, the distal end 8 and opening 7 have cross-sections of anoval shape or those with at least one defined angle to include obtuse,acute, and right angles. The cross-section of the distal end 8 andopening 7 can be provided in a shape that is more congruent with thesize or shape of the annulotomy of a patient's particular disc space.

Referring now in detail to FIG. 1B, a plunger 12 according to oneembodiment is shown for use with the hollow tube 2 of FIG. 1A. Theplunger 12 is generally of the same geometry and dimensions as thehollow portion of the hollow tube 2, extending at least the same lengthof hollow tube 2. The plunger 12 may include, as depicted in FIG. 1B, atleast one knob or handle 16 for grasping by a user of the plunger 12. Aswith the interior of the hollow tube 2 at its second end 8, the plunger12 also comprises at least one sloped or curved surface 20 at oradjacent to a second end 18 of the plunger 12. The plunger 12 terminatesin a generally flat surface 19, which corresponds to the opening 7 ofthe second end 8 of the hollow tube 2 shown in FIG. 1A. Thus, incooperation, the plunger 12 may be inserted into the opening 4 of thehollow tube 2 shown in FIG. 1A, and extended the entire length of thehollow tube 2, at least to a point where the flat surface 19 of plunger12 is in communication with the opening 7 of the second end 8 of thehollow tube 2. This configuration permits a user to eject substantiallyall of the bone graft material that is placed into the hollow tube 2during a surgical procedure. One skilled in the art will appreciate thatthe plunger need not terminate in a generally flat surface to affect thesubstantial removal of all of the bone graft material placed into thehollow tube; more specifically, any shape that allows conformancebetween the internal contour of the distal end of the hollow tube andthe distal end of the plunger will affect the substantial removal of thebone graft material.

In the embodiment of FIGS. 1A-C, a contoured leading edge 20 is providedon the plunger 12 to correspond with the internal contour of distal end8 of the hollow tube 2 of the delivery device. This contoured plunger 12serves several purposes: First, it maintains the plunger 12 in adesirable rotational position with respect to the hollow tube 2 (i.e.,prevents the plunger 12 from inadvertently or intentionally beingmanipulated to rotate about the longitudinal axis of the hollow tube 2).Second, it ensures that when the plunger 12 is fully inserted, theplunger 12 removes substantially all of the bone graft material from thehollow tube 2. Also, the contour of the plunger 12, corresponding to thecontour of the hollow tube 2, allows immediate identification of theorientation of the device, and more specifically, the direction of thebone graft material ejection into the surgical area (e.g., the patient'sintervertebral area). Alternative positioning means may also be providedto ensure that the plunger 12 remains in the desirable position duringdelivery of bone graft into the hollow tube 2, for example by a machinedbevel or edge on the outer surface of the plunger 12, and acorresponding groove in the interior surface of the hollow tube 2 (notshown), which must be aligned when inserting the plunger 12 in thehollow tube 2.

Referring now to FIG. 1C, an elevation view of the hollow tube 2 shownin FIG. 1A is shown in detail. The opening 7 of the second end 8 of thehollow tube 2 has a height A and width B. The height A and width B areselected based on various factors, including, but not limited to, theneeds of the surgeon, the location of the bone graft receiving area, thenature of the surgical operation to be performed, and the quantity andtype of bone graft that is being inserted in (and ultimately ejectedfrom) this integrated fusion cage and graft delivery device. Accordingto a preferred embodiment, the height A of the opening 7 is in the rangeof 4 mm to 9 mm, and in a most preferred embodiment is about 7 mm.According to a preferred embodiment, the width B of the opening 7 is inthe range of 7 mm to 14 mm, and in a most preferred embodiment is about10 mm.

Although FIGS. 1A-C show an embodiment where the second end 8 of thehollow tube 2, and the second end 18 of the plunger 12 comprise a curvedor sloped surface which extends at least a certain distance laterallyaway from the generally longitudinal axis of the hollow tube 2/plunger12, it is to be understood that in other embodiments, the second end 8of the hollow tube 2 (and thus, the second end 18 of the plunger 12) donot extend a lateral distance away, but rather terminate along thelongitudinal wall of the hollow tube 2. In this embodiment, the hollowtube 2 may have a second end 8 which has an opening 7 that is carved outof the side of the wall of the hollow tube 2, such that it appears as awindow in the tubular body of hollow tube 2. According to thisembodiment, the plunger 12 would still retain the curved or slopedsurface 20 at the opposite end of the flat surface 19 (see FIG. 1B) andsimilarly the hollow tube 2 would still comprise a sloped or curvedsurface 10 opposite the opening 7 at the second end 8. It is to beexpressly understood that other variations which deviate from thedrawing FIGS. 1A-C are also contemplated with the present invention, solong as that the opening 7 at the second end 8 of hollow tube 2 isoriented to permit bone graft to be ejected from the hollow tube 2 in agenerally lateral direction (in relation to the longitudinal directionof the axis of the hollow tube 2).

According to another embodiment, the plunger 12 shown in FIG. 1B mayfurther comprise a secondary handle (not shown), which includes anopening about at least one end of secondary handle such that it ispermitted to couple with handle 16 of plunger 12. In this fashion, thesecondary handle may be larger, contain one or more rings or aperturesfor placing a user's hand and/or fingers, or may simply be of a moreergonomic design, for accommodating use of the plunger 12 during asurgical operation. The secondary handle, according to this embodiment,is selectively removable, which permits a surgeon to use the secondaryhandle for inserting the plunger 12, and then at a later point removethe secondary handle, for instance, to improve visibility through theincision or through the hollow tube 2, and/or to determine whethersubstantially all of the bone graft material has been ejected from thehollow tube 2.

Referring now to FIGS. 2-6, a preferred embodiment of the device isshown. In regard to FIG. 2, an integrated fusion cage and graft deliverydevice portion is shown, comprised of a hollow tube 2, which has a firstproximate end 6 and a second distal end 8, with a general hollowstructure therebetween. The hollow tube 2 is shown with one of twolateral openings, 7A, at the distal end 8 of the tubular member 2viewable (the other of the openings, 7B, is viewable in FIG. 3). Theplunger 12 is also shown in FIG. 2. The manner of insertion of theplunger 12 into the hollow tube 2 is also shown in FIG. 2. The hollowtube 2 allows bone graft material to be inserted into the opening 4 atthe proximal end 6 of the hollow tube 2, and ultimately ejected from thehollow tube 2 through the lateral openings 7A, 7B at the distal end 8.

FIG. 2 shows a preferred embodiment of the distal end 8 of the tubularmember 2 and the distal end 18 of the plunger member 12. Theconfiguration provided, a wedge-shaped end 50 of the hollow tube 2 and awedge-shaped end 52 of the plunger 12, allows substantially all of thebone graft material to be removed and thus inserted into the surgicalarea when the plunger 12 is fully inserted into the hollow tube 2. Thewedge-shape 50 of the distal end 8 of the tubular member 2 and thewedge-shaped end 52 of the plunger 12 is discussed in additional detailwith respect to FIGS. 4 and 5 below. The ability to remove substantiallyall of the bone graft material is an important feature of the inventionbecause bone graft material is traditionally expensive and may requiresurgery to obtain.

Referring now to FIG. 3, a perspective view of a preferred embodiment ofthe hollow tube 2 is provided. Consistent with FIG. 2, the hollow tube 2is shown with one of two lateral openings, 7B, at the distal end 8 ofthe hollow tube 2 viewable (the other lateral opening, 7A, is viewablein FIG. 2). Thus, in operation the hollow tube 2 allows bone graftmaterial to be inserted into the opening 4 at the proximal end 6 of thehollow tube 2, and ultimately ejected from the hollow tube 2 through thelateral openings 7A, 7B at the distal end 8 of the hollow tube 2. Inthis configuration, bone graft material is ejected into the surgicalarea in two lateral directions. One skilled in the art will appreciatethat the openings 7A, 7B at the distal end 8 of the hollow tube 2 neednot be positioned exclusively on one or more lateral sides of the distalend 8 of the tube 2 to allow bone graft material to be provided to thesurgical site in other than a purely axial or longitudinal direction.Further, one skilled in the art will appreciate that the specificabsolute and relative geometries and numbers of lateral openings mayvary, for example the distal end 8 of the hollow tube 2 may have morethan two openings that are of different shape (e.g. oval, rectangular),and/or one or more lateral openings may comprise a first pair of edgesand a second pair of edges, wherein the first pair of edges are straightand the second pair of edges are not straight.

Referring now to FIG. 4, an elevation view of the wedge-shaped distalend 50 of the hollow tube 2 is provided. In this embodiment, the distalend 52 of the plunger 12 conforms to the same wedge shape as the distalend 50, to allow close fitting of the plunger 12 and the hollow tube 2.This contoured plunger 12, corresponding to the contoured hollow tube 2,serves several purposes: First, it maintains the plunger 12 in adesirable rotational position with respect to the hollow tube 2 (i.e.,prevent the plunger 12 from inadvertently or intentionally beingmanipulated to rotate about the longitudinal axis of the hollow tube 2);Second, it ensures that when the plunger 12 is fully inserted, theplunger 12 removes substantially all of the bone graft material from thehollow tube 2. Also, the contoured plunger 12, corresponding to thecontoured hollow tube 2, allows immediate identification of theorientation of the device, and more specifically the direction of thebone graft material ejection into the surgical area. One skilled in theart will appreciate that the plunger 12 need not terminate in awedge-shape surface 52 to affect the substantial removal of all of thebone graft material placed into the hollow tube 2; more specifically,any shape that allows conformance between the internal contour of thedistal end 50 of the hollow tube 12 and the distal end 52 of the plunger12 will affect the substantial removal of the bone graft material.

Referring now to FIG. 5, an elevation view of the opening 4 of theproximal end 6 of the hollow tube 2 is provided. As shown in FIG. 5, theopening 4 at the proximal end 6 of the hollow tube 2 allows deposit ofbone graft material. In this configuration, the cross-section of theopening 4 at the proximal end 6 of the hollow tube 2 is generallysquare. Although a generally square cross-section is depicted, thecross-section need not be limited to a generally square shape. Forexample, in various embodiments, the proximal end 6 and opening 4 havecross-sections of an oval shape or those with at least one defined angleto include obtuse, acute, and right angles. The cross-section of theproximal end 6 and opening 7 can be provided in a shape that is morecongruent with the size or shape of the annulotomy of a patient'sparticular disc space.

Referring now to FIGS. 6A-D, sequential elevation views of oneembodiment of the integrated fusion cage and graft delivery device 1 areprovided, depicting the complete insertion of the plunger 12 into thehollow tube 2. In each of FIGS. 6A-D, the wedge-shaped distal end 50 ofthe hollow tube 2 is depicted. Also, each of FIGS. 6A-D depict theadditional length of the plunger 12 when inserted into the tubularmember 2 (i.e., the portion of the plunger 12 that extends outside ofthe hollow tube 2). FIG. 6A shows one of two lateral openings 7A at thedistal end 8 of the hollow tube 2. FIG. 6C shows another of the twolateral openings 7B at the distal end 8 of the hollow tube 2. Oneskilled in the art will appreciate that the openings 7A, 7B at thedistal end 8 of the hollow tube 2 need not be positioned exclusively onone or more lateral sides of the distal end 8 of the hollow tube 2 toallow bone graft material to be provided to the surgical site in otherthan a purely axial or longitudinal direction. Further, one skilled inthe art will appreciate that the specific absolute and relativegeometries and numbers of lateral openings 7A, 7B may vary, for examplethe distal end 8 of the hollow tube 2 may have more than two openingsthat are of different shape (e.g. oval, rectangular). In variousembodiments, the sizes and dimensions of lateral openings 7A and 7B aredifferent from one another, as shown in FIGS. 2, 3, 6A and 6C. In otherembodiments, the sizes and dimensions of lateral openings 7A and 7B arethe same.

Referring now to FIGS. 7A to 7F, an embodiment of an integrated fusioncage and graft delivery device 1 of the present disclosure isillustrated. The graft delivery device generally includes a cannular orhollow tube 2, a plunger 12, and a detachable funnel 30.

The hollow tube 2 is the same as, or similar to, other embodiments ofhollow tubes described herein. Accordingly, the hollow tube 2 generallyincludes an opening 4 at a proximal end 6. At least one dischargeopening 7 is associated with a distal end 8 of the hollow tube. Thehollow tube 2 has a pair of first, exterior side surfaces 3 that extendbetween the proximal and distal ends 6, 8 (see FIG. 7C), as well as apair of second, exterior top and bottom surfaces 5 that also extendbetween the proximal and distal ends 6, 8 (see FIG. 7B). In oneembodiment, the discharge opening 7 is positioned transverse to alongitudinal axis of the hollow tube 2. Accordingly, in one embodiment,the distal end 8 is at least partially closed opposite to the proximalopening 4. Alternatively, the distal end 8 may be completely closed.Optionally, a discharge opening 7 may be formed through at least aportion of the distal end. Specifically, in one embodiment, the hollowtube 2 can include a discharge opening 7 aligned with a longitudinalaxis of the hollow tube.

In one embodiment, the distal end 8 is rounded or smooth with a wedgeshape 50. Specifically, the distal end 8 can have a shape configured tofacilitate easy entry into a disc space. In this manner, the shape ofthe distal end 8 minimizes soft tissue damage or irritation. The wedgeshape 50 enables insertion of the distal end 8 into a collapsed discspace without damaging the endplates or skating off to an unintendedlocation. In contrast, some prior art devices with an open distal endcan injure bony end plates of the disc space of a patient.

In an embodiment, the hollow tube 2 includes two discharge openings 7A,7B. The two discharge openings 7A, 7B can be arranged on opposite sidesof the hollow tube 2 to eject graft material therefrom. Accordingly, inone embodiment, the hollow tube 2 is operable to dispense bone graftmaterial laterally away from a longitudinal axis of the graft deliverydevice 1. In one embodiment, the two discharge openings 7A, 7B are ofsubstantially the same size and shape. In one embodiment, the dischargeopenings 7A, 7B have a generally oval shape. In various otherembodiments, the discharge openings 7A, 7B do not have the same size orshape as each other. In various embodiments, the discharge openings 7A,7B have rectangular, rhomboid, circular or other shapes.

In another embodiment, at least one opening 7C (illustrated in FIG. 7D)is formed in the distal end 8. Thus, the graft delivery device 1 maydischarge bone graft material through the distal end 8 in line with thelongitudinal axis of the graft delivery device 1. The opening 7C mayhave any predetermined shape. In various embodiments, the opening 7C hasa rectangular, round, or ovoid shape. In an embodiment, the distal end 8includes a taper or wedge shape 50 with the end opening 7C formedtherethrough.

The hollow tube 2 is substantial hollow between the proximal end 6 andthe distal end 8. Specifically, a lumen 28 extends through the hollowtube 2 (see FIG. 7A). The lumen 28 has a predetermined cross-sectionalshape. In various embodiments, the cross-sectional shape of the lumen isround, ovoid, square, or rectangular. In another embodiment, theinterior of the lumen 28 is not round and is, for example, rectangular.In one embodiment the cross-sectional shape of the lumen 28 issubstantially uniform along the length of the hollow tube 2. In oneembodiment, the lumen 28 has a uniform cross-sectional size along itslength. In various embodiments, the exterior of the hollow tube 2 has ashape that is one of round, ovoid, square, and rectangular.

In various embodiments, a ramp 9 is formed within the hollow tube 12,proximate to the opening 7. As described herein, the ramp 9 includessurfaces configured to direct the bone graft material away from theopening 7 into a surgical site, such as a disc space. More specifically,the ramp 9 functions as a reverse funnel to disperse bone graft materialejected from the opening 7 as generally illustrated in FIG. 7A.

In one embodiment, surfaces of the ramp 9 are linear in shape, that is,forming a triangle in cross-section. In other configurations, surfacesof the ramp 9 are of any shape that urges egress of bone graft materialcontained in the hollow tube to exit the lumen 28 of the hollow tube 2through the at least one opening 7 of the device 1.

With continued reference to FIG. 7A, the hollow tube 2 is configured toreceive the plunger 12 of the present disclosure within the lumen 28.Any plunger 12 of the present disclosure may be used with the hollowtube 2. The plunger 12 is used to push bone graft material positioned inthe lumen 28 out of the opening 7 at the distal end 8. In oneembodiment, a stop 16A can be formed on the plunger 12 to engage theproximal end 6 of the hollow tube. In this manner, the stop 16A preventsover insertion of the plunger within the lumen.

In various embodiments, the plunger 12 includes a plurality of teethseparated by notches 27. The notches 27 can be engaged by a means foradvancing bone graft material, as described herein. In one embodiment,the advancing means comprises a ratchet configured to engage the notches27. In operation, the ratchet can engage successive notches to advanceor withdraw the plunger within the hollow tube 12.

Additionally, or alternatively, the means for advancing can include agear with teeth. The gear is aligned with the plunger 12 and operable toconvert rotational movement of the rear to linear movement of theplunger 12. As the gear rotates, the gear teeth engage the plungernotches 27 to move the plunger toward or away from the hollow tubedistal end.

In still another embodiment, the advancing means comprises a worm gearwith at least one helical thread. As the worm gear rotates, the helicalthread engages the plunger notches 27. In this manner, the worm gear canadvance or retract the plunger 12 within the hollow tube 2.

The plunger 12 includes a distal end 18. The distal end 18 substantiallyconforms to inner walls of the lumen 28. Specifically, in oneembodiment, the distal end 18 has a cross-sectional shape whichcorresponds to the interior shape of the lumen 28. In variousembodiments, the plunger distal end 18 is round, ovoid, square, orrectangular. In one embodiment, the distal end 18 is not round. Inanother embodiment, the distal end 18 of the plunger 12 is configured tocontact the inner walls of the lumen 28 about an entire outer peripheryof the plunger distal end 18. Additionally, or alternatively, theplunger 12 (or a portion thereof) may be made of rubber silicone toimprove the seal with interior surfaces of the lumen 28. In variousembodiments, at least the distal end 18 is made of a plastic or anelastomeric rubber.

In one embodiment, the plunger 12 has a length sufficient for the distalend 18 of the plunger 12 to extend beyond the opening 7 as generallyillustrated in FIG. 7C. In one embodiment, the handle 16 of the plunger12 is a planar disk shape, as depicted in FIG. 7C. In anotherembodiment, handle 16 is not planar. For example, handle 16 can beangled so as to conform to interior of funnel 30 when the plunger 12 isfully inserted into hollow tube 2.

In various embodiments, at least one vent port 21 can be formed throughthe hollow tube 2 to the lumen 28. The vent port 21 is configured torelease air from the interior of the hollow tube 2 as bone graftmaterial is delivered to the distal end 8 for discharge out of theopening 7. As one of skill in the art will appreciate, air trappedwithin the lumen 28 of the hollow tube 2 between the distal end 8 andbone graft material may increase the amount of axial force required bythe plunger 12 to move the bone graft material to the discharge opening7 or may cause the plunger 12 to jam or bind in the lumen 28. Applyingexcessive force to the plunger 12 to eject the bone graft material cancause soft tissue inflammation or damage. By allowing air to escape fromwithin the lumen 28 of the hollow tube 2 as the plunger 12 is pressedtoward the distal end 8, the vent port 21 may decrease the amount offorce required to deliver the bone graft material to the dischargeopening 7. The possibility of the plunger 12 jamming within the hollowtube 2 is also reduced. Specifically, the vent port 21 eliminates orreduces the risk of jamming the plunger and also reduces the possibilityof trapped air being forced into the disc space and into the patient'svascular system causing an air embolism.

The vent ports 21 also prevent introduction of air or other fluids intothe surgical site. For example, air may be introduced into, and trappedwithin, bone graft material as the bone graft material is loaded intothe hollow tube 2. As the plunger 12 is pressed against the bone graftmaterial, the air may be released from the bone graft material. The aircan escape from the lumen 28 through the vent ports 21.

Vent ports 21 can be formed through the hollow tubes 2 of allembodiments of the present disclosure. Vent ports 21 may be formed atany location along the length of the hollow tube 2 between the proximalend 6 and the distal end 8. In one embodiment, a vent port 21 is formedon at least one of the first surface 3 and the second surface 5. In oneembodiment, vent ports 21 can be formed on more than one surface 3, 5 ofthe hollow tube.

The at least one vent port 21 is configured to prevent discharge of bonegraft material from the lumen 28. Accordingly, the vent port 21 has oneor more of a size and a shape selected to prevent passage of bone graftmaterial therethrough. In one embodiment, a width or a diameter of thevent port is less than approximately 2 mm. In one embodiment, the ventport 21 includes a mesh or screen with apertures which allow passage ofair therethrough.

As illustrated in FIG. 7B, the vent port 21 can optionally have agenerally circular shape, such as a bore. Although the vent port 21illustrated in FIG. 7B is generally circular, other shapes arecontemplated. In one embodiment, the vent port is a slit or slot. Theslot may be generally linear. In another embodiment, the vent port 21has a shape that is generally triangular or rectangular. Specifically,the vent port 21 may have any size or shape which allows the passage ofair but prevents passage of bone graft material therethrough.

Any number of vent ports 21 may be formed through the hollow tube 2. Inone embodiment, the hollow tube 2 includes at least three vent ports 21.A first vent port 21A can be proximate to the proximal end 6 of thehollow tube 2. A second vent port 21B can be proximate to the distal end8. A third vent port 21C can be formed between the first and second ventports 21A, 21B.

In some embodiments, the plunger 12 includes a channel 35 (such asgenerally illustrated in FIG. 7A) that is configured to release air fromthe distal end 8 of hollow tube 2 (e.g., the lumen 28) to the proximalend 6 of the hollow tube 2. In this manner, as the plunger 12 isadvanced to eject bone graft material from the discharge opening 7, airtrapped in the bone graft material and/or the distal end 8 (e.g., theportion of the lumen 28 that is distal to the distal end 18 of theplunger 12) can pass through the channel 35 into the proximal portion ofthe lumen 28.

In some embodiments, indicia 29 can be formed on one or more surface ofthe hollow tube 2 (see FIG. 7B). The indicia are configured to indicatea depth of insertion of the distal end 8 of the hollow tube 2 into asurgical site. The indicia 29 can include marking and numerals. Invarious embodiments, one or more of the indicia 29 is radiopaque. Invarious embodiments, the indicia 29 extends along the entire length ofthe hollow tube 2, or along a predetermined portion of the length.

In one embodiment, the hollow tube 2 may comprise a first portion 22 anda second portion 23 which are configured to be interconnected. Thehollow tube 2 thus includes a joint 24, illustrated in FIG. 7C, alongwhich the first and second portions 22, 23 are connected. The joint 24may substantially bisect the hollow tube 2.

The first and second portions 22, 23 can be interconnected by anysuitable means. In one preferred embodiment, an ultraviolet activatedadhesive is used to interconnect the first and second portions 22, 23.This forms a particularly strong bond in combination with optionalalignment features 25, 26 (best seen in FIG. 7E) and the material of thehollow tube 2.

In another embodiment, the first and second portions 22, 23 aresonically welded together. Additionally, or alternatively, one or moreglues or adhesives can be used to join the first and second portions 22,23.

In one embodiment, the first and second portions 22, 23 can include thealignment features 25, 26. In addition to ensuring alignment of thefirst portion 22 with respect to the second portion 23 when the hollowtube 2 is assembled, the alignment features 25, 26 can also providesupport to the hollow tube 2. In one embodiment, the alignment features25, 26 have a shape selected to increase rigidity of the hollow tube 2,such as to prevent unintended or inadvertent bending or movement.

The alignment features 25, 26 may comprise a projection 25 formed on oneof the first and second portions 22, 23 that is at least partiallyreceived in a bore or aperture 26 of another of the first and secondportions 22, 23. In one embodiment, the alignment feature 25 comprises apeg or pin. In one embodiment, alignment feature 26 comprises a recessconfigured to receive the peg 25. In one embodiment, one of thealignment features 25, 26 comprises a flange. The flange may extendalong some or all of the joint 24. The other one of the alignmentfeatures 26, 25 may comprise a groove configured to receive the flange.Similar to the flange, the groove may extend along some or all of thejoint 24. Other shapes and features of the alignment features 25, 26 arecontemplated.

The alignment features 25, 26 can also be configured to lock the firstand second portion 22, 23 together. Specifically, in one embodiment,alignment feature 25 comprises a projection configured to engage acorresponding recess in alignment feature 26. Feature 26 canfrictionally engage feature 25.

In various embodiments, the hollow tube 2 is made of a flexible,semi-rigid, or rigid material including, but not limited to, one or moreof a plastic, a composite, a metal. In one embodiment, the hollow tube 2is formed of polycarbonate resin thermoplastic. In one embodiment, atleast a portion of the hollow tube 2 is radiopaque. In one embodiment,at least the distal end 8 is radiopaque or includes radiopaque markers,such as indicia 29. In one embodiment, the hollow tube 2 issubstantially rigid. In one embodiment, at least a portion of the hollowtube 2 is flexible. For example, in one embodiment, at least aboutone-half of the hollow tube 2 comprising the distal end 8 is flexible.

In one embodiment, the hollow tube 2 is generally linear. Alternatively,the hollow tube 2 can include a portion that is not linear. Morespecifically, in one embodiment, the hollow tube 2 can have a permanent(or temporary) curve or bend.

In another embodiment, the proximal end 6 of the hollow tube extendsalong a first longitudinal axis. At least the distal end 8 of the hollowtube 2 may extend along a second longitudinal axis that is transverse tothe first longitudinal axis of the proximal end. The distal end 8 canextend at a predetermined angle from the proximal end 6. In variousembodiments, the angle can be between about 0° and about 75°. In oneembodiment, the distal end 8 intersects the proximal end 6 at a joint.The joint may be adjustable such that a user can alter the angle betweenthe proximal end 6 and the distal end 8. Alternatively, the joint is notadjustable. The proximal end 6 and the distal end 8 may each extendgenerally linearly to the joint. Alternatively, the hollow tube 2 mayinclude a transition portion between the proximal end 6 and the distalend 8. The transition portion can have a shape that is curved, such asan elbow joint.

In one embodiment, the hollow tube 2 is made of a substantiallytransparent or translucent material, and the hollow tube 2 is notopaque. In one embodiment, at least a portion of the hollow tube 2 istransparent or translucent. In one embodiment, the hollow tube 2includes windows of a transparent or translucent material. Accordingly,in some embodiments, the plunger 12 is at least partially visible withinthe lumen 28 of the hollow tube.

Referring now to FIGS. 7D, in various embodiments, the hollow tube 2includes one or more image sensing devices 36. In various embodiments,the image sensing device(s) 36 includes, without limitation, one or moreof an endoscope, a camera and/or an image sensor that is/are operablycoupled to the hollow tube 2. Other types of image sensing devices knownto one skilled in the art are also contemplated. In various embodiments,the image sensing device(s) 36 is removably or permanently coupled tothe hollow tube 2. In one embodiment, the image sensing device(s) 36extends through a portion of the hollow tube 2 (see FIG. 7G). In anotherembodiment, the image sensing device 36 is interconnected to an exteriorsurface (i.e., side surface 3 and/or top/bottom surface 5) of the hollowtube 2. Additionally, or alternatively, the image sensing device 36extends within at least a portion of the lumen 28. In various alternateembodiments, the image sensing device(s) 36 is positioned on the plunger12.

In one embodiment, the image sensing device(s) 36 is oriented to view atleast the distal end 8 of the hollow tube 2. Optionally, the imagesensing device(s) 36 is repositionable with respect to the distal end 8.In this manner, the image sensing device 36 can be manipulated to viewone or more openings 7 of the hollow tube 2, or view the internal aspectof the disc space 172A (see FIG. 7G), or a debrided portion of the discspace 172A, prior to administration of bone graft.

In another embodiment, the hollow tube 2 can include one or morelighting elements 37 (see FIG. 7D). In various embodiments, the lightingelement(s) 37 is operably associated with the image sensing device 36.Additionally, or alternatively, one or more lighting elements 37 can befixed to, or integrally formed with, the hollow tube 2. Suitablelighting elements, cameras, and displays that may be used with theintegrated fusion cage and graft delivery device 1 of the presentdisclosure are described in U.S. Pat. Nos. 8,864,654, 9,717,403, and PCTPub. WO 2012/145048, which are each incorporated herein by reference intheir entirety. Other types of lighting elements known to one skilled inthe art are also contemplated

As illustrated in FIGS. 7B and 7C, the funnel 30 can be releasablyinterconnected to the hollow tube 2. The funnel 30 facilitates loadingof bone graft material into the opening 4 at the proximal end 6 of thehollow tube 2. Once the lumen 28 is loaded with bone graft material, thefunnel may be removed to improve visualization of the distal end 8 andopening 7 in a surgical site, such as a disc space. In contrast to priordevices which include a fixed funnel which cannot be removed, thereleasable funnel 30 of the present disclosure does not obstructvisualizing the distal end 8 of the hollow tube 2 as it is placed in adisc space or other surgical site. In one embodiment, if additional bonegraft material is required, the funnel 30 is interconnected to thehollow tube 2 during the surgical procedure without having to remove thehollow tube 2 from the surgical site, decreasing the potential trauma toadjacent nerve tissue. The funnel 30 is releasably interconnected to thehollow tube 2. In one embodiment, the funnel 30 is retained on thehollow tube 2 by a friction fit. Alternatively, the funnel 30 can snaponto the hollow tube. In one embodiment, the hollow tube 2 includes acollar 6A with one or more projection 6B (see FIG. 7B), and the funnel30 has a sleeve 32 that fits over the collar 6A and engages theprojection 6B. In one embodiment, the sleeve 32 includes a slot 33 toengage the projection 6B. The slot 33 and projection 6B form a bayonetmount in one embodiment. Other connection mechanisms are contemplated,as known in the art.

In various embodiments, the hollow tube 2 is configured to receive afusion cage 60 of one or more of the embodiments described herein. Inone embodiment, the fusion cage 60 has a fixed height. Alternatively,the fusion cage 60 is expandable after placement in a disc space.

In one embodiment, the fusion cage 60 includes an opening 65 todischarge bone graft material therethrough (see FIG. 7C). The opening 65is alignable with the opening 7 of the hollow tube 2. In one embodiment,the fusion cage 60 includes two or more openings 65 which eachcorrespond to openings 7A, 7B of the hollow tube 2. Accordingly, as bonegraft material is advanced through the lumen 28 and through the opening7 of the hollow tube 2, the bone graft material will be dischargedthrough opening(s) 65 of the fusion cage 60 into a surgical site, suchas a disc space.

In one embodiment, a distal end 64 of the fusion cage 60 is closed. Thedistal end 64 may have a blunt or tapered shape similar to thewedge-shaped end 50 of the hollow tube 2.

In one embodiment of the device 1, the width of the hollow tube 2'sfirst, exterior side surfaces 3 is between 5 and 11 mm. In anotherembodiment, the width of these exterior side surfaces 3 is between 7 and9 mm. In another embodiment, the width of these exterior side surfaces 3is between 7.5 mm and 8.5 mm. In yet another embodiment, the width ofthese exterior side surfaces 3 is 8 mm. In one embodiment of the device1, the width of the hollow tube 2's second, exterior top and bottomsurfaces 5 is between 9 and 15 mm. In a preferred embodiment, the widthof these exterior top and bottom surfaces 5 is between 11 and 13 mm. Inanother embodiment, the width of these exterior top and bottom surfaces5 is between 11.5 mm and 12.5 mm. In yet another embodiment, the widthof these exterior top and bottom surfaces 5 is 12 mm.

In one embodiment of the device, the ratio of the width of the hollowtube 2's second, exterior top and bottom surfaces 5 to the width of thehollow tube 2's first, exterior side surfaces 3 is between approximately1.7 and 1.3. In another embodiment, this ratio is between 1.6 and 1.4.In still another embodiment, this ratio is between 1.55 and 1.45. Inanother embodiment, this ratio is 1.5.

In one embodiment of the device 1, a first interior width of the hollowtube 2 along a minor axis between the two first, side exterior surfaces3) is between 5 and 9 mm. In another embodiment, the first interiorwidth is between 6 and 8 mm. In yet another embodiment, the firstinterior width is between 6.5 mm and 7.5 mm. In still anotherembodiment, the first interior width is 7 mm. In one embodiment of thedevice 1, a second interior width of the hollow tube 2 along a majoraxis between the second exterior top and bottom surfaces 5 is between 9and 13 mm. In another embodiment, the second interior width is between10 and 12 mm. In yet another embodiment, the second interior width isbetween 10.5 mm and 11.5 mm. In still another embodiment, the secondinterior width is 11 mm.

In one embodiment of the device 1, the ratio of the second interiorwidth to the first interior width is between approximately 1.7 and 1.3.In another embodiment, this ratio is between 1.6 and 1.4. In anotherembodiment, this ratio is between 1.55 and 1.45. In yet anotherembodiment, this ratio is 1.5.

In one embodiment, one or more edges of the device 1 are rounded. Forexample, exterior edges of the hollow tube 2 are rounded, and/orinterior edges of the hollow tube 2 are rounded. In this embodiment,edges of the plunger 12 (at least at the plunger's distal end 18), areidentically rounded to ensure a congruous or conformal fit between edgesof the plunger 12 and the interior of the hollow tube 2 so as to, amongother things, urge the majority of bone graft material to move throughthe hollow tube 2.

In various embodiments, the device 1 is formed using a three-dimensionalprinting process. More specifically, one or more of the hollow tube 2,the plunger 12, the funnel 30, and/or the fusion cage 60 aremanufactured by one or more three-dimensional printing processes. Avariety of materials, including metals, PEEK, other plastics and/orcombinations of such materials, are used in a three-dimensional printerto form the device 1 in various embodiments.

Referring now to FIG. 7F, devices 42A and 42B for preparing a bone graftmaterial 44 according to one embodiment of the present disclosure areillustrated. Specifically, in one embodiment, bone graft material 44 isprepared within one or more devices 42, such as, for example, graduatedsyringes. The bone graft material 44 is compressed or compacted to forma desired and measured amount of bone graft material. In variousembodiments, the bone graft material 44 comprises two components, suchas, for example an activating agent or a liquid 44A and a dry materialor a granular material 44B. The bone graft material components 44A, 44Binclude other substances in other embodiments. In various otherembodiments, the bone graft material 44 includes more than twocomponents, for example, three, four, five or ten components.

Referring again to FIG. 7F, the bone graft components 44A, 44B are mixedtogether by interconnecting the devices 42A, 42B. In one embodiment, thedevices 42A, 42B are interconnected with a bayonet mount. In oneembodiment, a connecting device 46 is provided to interconnect device42B to device 42A. Connecting device 46 may include luer locks. The luerlocks may include a locking or slip style connector. A bore 48 throughthe connecting device 46 enables bone graft material components 44Aand/or 44B to be injected from one syringe 42A/42B to the other syringe42B/42A. In one embodiment, component 44B is injected from device 42Binto device 42A to be mixed with bone graft component 44A.

Once mixed, the bone graft material 44 (i.e., mixed components 44A, 44B)are subsequently be discharged from device 42A into the hollow tube 2.In one embodiment, the device 42A can be interconnected to the proximalend 6 of the hollow tube 2. Additionally, or alternatively, the bonegraft material 44 can be ejected from the device 42A into the funnel 30.Suitable devices 42 that can be used to prepare bone graft material foruse with the integrated fusion cage and graft deliver device 1 of thepresent disclosure are known and described in U.S. Pat. Pub.2009/0124980, U.S. Pat. Pub. 2014/0088712, U.S. Pat. Pub. 2014/0276581,U.S. Pat. Pub. 2014/0371721, U.S. Pat. Nos. 8,439,929 and 9,174,147which are each incorporated herein by reference in their entirety.

The integrated fusion cage 60 and graft delivery device 1 of the presentinvention provides many benefits over other devices. For example, therectangular lumen 28 of embodiments of the hollow tube 2 affords severaladvantages over conventional circular configurations. For a surgicalarea with a smallest dimension set at a width of 8 mm and a thicknessdimension 0.5 mm, a conventional circular device (with resultinginterior diameter of 7 mm or a radius of 3.5 mm) would realize a surfacearea of 38.48 mm². In contrast, the device of the present inventionwould carry interior dimensions of 7 mm by 11 mm for a surface area of77 mm, an increased surface area factor of nearly 2.0, thereby resultingin more bone graft material delivery. This is at least in because, amongother things, a given volume of bone graft encounters less surface areaof the interior of a larger device which results in, among other things,a reduced likelihood of bone graft material becoming jammed within thedevice.

Referring now to FIG. 8, a conventional prior art bone graft deliverydevice 170 provided in combination with a surgical work site 172 isillustrated. Specifically, a bone graft delivery device 170 is shown asproviding a bone graft material 44 to an intervertebral space 172 withina human spine. The tool 170 is generally inserted into a patient from atransforaminal or lateral access site, and a second end of the deliverydevice 170 is provided within the intervertebral space to which bonegraft material 44 is to be provided. The device 170 includes aconventional end-dispensing lumen 170 a that ejects and injects the bonegraft material 44 directly into the intended path of a fusion cage. Thedevice and method of FIG. 8 does not distribute bone graft deliverymaterial into the periphery of the prepared disc space and generallyfails to achieve appropriate distribution of bone graft deliverymaterial within the disc space 172. Additionally, the small diametertube necessitates injecting the bone graft material 44 in a more liquid(less viscous) state. In some cases, the pressure required to push bonegraft material through the bore of device 170 is relatively high,increasing the risk of the device jamming. Generally, the risk of injuryto the patient increases as the pressure required to eject the bonegraft material from the delivery device 170 increases. Furthermore, ifthe device jams, then it needs to be removed, increasing the cumulativetrauma to the surrounding nerve tissue as the device is removed andreinserted.

Referring now to FIG. 9A, an integrated fusion cage and graft deliverydevice 1 according to embodiments of the present disclosure isillustrated delivering bone graft material 44 to a disc space 172 withina patient's spine 171. As shown, the hollow tube 2 of the device 1 isprovided with at least one side opening 7. Bone graft material 44 isprovided to the intervertebral space 172 by ejecting the material fromthe side opening 7. In some embodiments, the hollow tube 2 has two sideopenings 7 such that bone graft material 44 is ejected on opposing sidesof the device 1. In this manner, the device 1 provides enhanceddistribution of bone graft material 44 and a greater quantity of bonegraft material into a surgical site compared to the device 170 describedin conjunction with FIG. 8. Further, the larger cross-sectional shape ofthe hollow tube 2 of the delivery device 1 of the present inventionallows injection of bone graft material in a thicker, more controllableviscous state and with less force than required by the device 170.

An additional benefit of some embodiments of the graft delivery device 1of the present disclosure is that they avoid injection of bone graftmaterial 44 directly into the path or intended path of a cage, such asdone by the device 170 illustrated in FIG. 8. For example, FIG. 9Bprovides a top view of the surgical workspace 172 according to FIG. 9A,after the integrated fusion cage and graft delivery device 1 has beenremoved after insertion or injection of the bone graft material 44. Asshown in FIG. 9B, removal of the bone graft delivery device 1 providesan unobstructed path 174 and void space for subsequent insertion of afusion cage (not shown in FIG. 9B). In this manner, the graft deliverydevice 1 of the present disclosure provides for a sufficient amount ofbone graft material 44 within the surgical site 172 and provides an area174 that is operable to receive a fusion cage.

In various embodiments, the graft delivery device 1 of the presentdisclosure is used in the surgical treatment of a collapsed/injuredvertebra. For example, in one embodiment, a surgeon introduces the graftdelivery device 1 (e.g., the hollow tube 2 thereof) into acollapsed/injured vertebra to create a cavity in the vertebra. Thesurgeon then fills the cavity with bone cement, to repair thecollapsed/injured vertebra.

In one embodiment of the foregoing surgical technique, the surgeon usesa pedicle screw to create an opening that functions as an opening orpathway to the collapsed/injured vertebral body, and then removes thepedicle screw. The surgeon then inserts the hollow tube 2 of the graftdelivery device 1 through the opening/passageway created by the pediclescrew. In various other embodiments, a surgeon may make and use any orall other commonly known surgical pathways to the interior of acollapsed/injured vertebrae, including, but not limited to, an anteriorapproach and a lateral approach.

In other embodiments, the fusion cage may be inserted into the collapsedvertebra, filled with bone cement and/or other materials, and left inplace.

Referring now to FIGS. 10-17, another embodiment of a graft deliverydevice 1 of the present disclosure is generally illustrated. The graftdelivery device 1 includes features that are the same as or similar toother graft delivery devices described herein, including those describedin conjunction with FIGS. 1-9. Notably, the graft delivery device 1generally includes a cannular or hollow tube 2, a plunger 12, and adetachable funnel 30.

The hollow tube 2 is the same as, or similar to, other embodiments ofhollow tubes of the present disclosure. Accordingly, the hollow tube 2generally includes an opening 4 at a proximal end 6. The opening 4provides access to a substantially hollow interior formed between theproximal end 6 and the distal end 8. The hollow interior defines a lumen28 that extends through the hollow tube 2.

The lumen 28 has a predetermined cross-sectional shape. In variousembodiments, the cross-sectional shape of the lumen 28 is round, ovoid,square, or rectangular. In another embodiment, the interior of the lumen28 is not round and is, for example, rectangular. In one embodiment thecross-sectional shape of the lumen 28 is substantially uniform along thelength of the hollow tube 2. In one embodiment, the lumen 28 has auniform cross-sectional size along its length. In various embodiments,the exterior of the hollow tube 2 has a shape that is one of round,ovoid, square, and rectangular. In one embodiment, the distal end 8 ofthe hollow tube 2 is rounded or smooth. The distal end can have awedge-shape. At least one discharge opening 7 is formed in the distalend 8 of the hollow tube 2. In one embodiment, the discharge opening 7is positioned transverse to a longitudinal axis of the hollow tube 2.More specifically, in one embodiment the discharge opening 7 can beformed in a first side surface 3A proximate to the distal end 8.Optionally, the opening 7 can extend to top and bottom surfaces 5A, 5Bof the hollow tube 2 as generally illustrated in FIGS. 11-12. As shownin FIGS. 11 and 12, because the opening 7 of one embodiment extends tothe top and bottom surfaces 5A, 5B the distal end 8 can have a width 70Bthat is less than a width 70A of a proximal portion of the hollow tube2.

Expanding the opening 7 in this manner facilitates the movement of bonegraft material laterally out of the hollow tube 2. More specifically, byextending the opening 7 in the inferior and superior directions to thetop and bottom surfaces 5A, 5B, the size of the opening 7 is increased.This feature minimizes the amount of horizonal travel (or turning) ofbone graft as it moves from the lumen 28 and is discharged out of theopening 7. Further bone graft material flowing in the lumen 28 to theopening 7 does not have to change direction or move vertically around anedge of the opening 7 such as would occur if the opening 7 were onlyformed in the first side 3A. For example, the opening 7 of theembodiment generally illustrated in FIGS. 11-12 does not include anyobstructions formed by portions of the first side 3A extending inwardlyfrom at least one of the top surface 5A and/or the bottom surface 5B. Inone embodiment, the first side 3A of the hollow tube 2 ends at theproximal portion of the opening 7. Because of this, the opening 7extends the entire height of the lumen 28 from the top surface 5A to thebottom surface 5B. Accordingly, there are no obstructions extending fromthe top and bottom surfaces 5A, 5B around which the bone graft materialmust flow or against which the bone graft material could becomecompacted or compressed such as to impede the flow of bone graftmaterial from the opening. The applicant has found that in this manner,less dense bone graft material, such as bone graft that has a fibrouscomposition similar to the consistency of a cotton ball, can bedischarged laterally out of opening 7. In contrast, some prior art bonegraft delivery devices cannot be used to discharge fibrous bone graftlaterally because the fibrous bone graft will compact and does not moveout of the prior art delivery devices. Additionally, the fibrous bonegraft can catch on edges of openings of some prior art delivery devices.

The hollow tube 2 is configured to receive the plunger 12 of the presentdisclosure within the lumen 28. The plunger 12 can be used to push bonegraft material positioned in the lumen 28 out of the opening 7 at thedistal end 8. Optionally, a stop 16A can be formed on the plunger 12 toengage the proximal end 6 of the hollow tube. In this manner, the stop16A prevents over insertion of the plunger within the lumen.

The plunger 12 is generally configured to substantially conform to innerwalls of the lumen 28. Specifically, in one embodiment, at least aportion of plunger 12 has a cross-sectional shape which generallycorresponds to the interior shape of the lumen 28. In variousembodiments, the plunger 12 has a cross section that is round, ovoid,square, or rectangular. In one embodiment, a cross section of theplunger 12 is not round. In another embodiment, at least a portion ofthe plunger 12 is configured to contact the inner walls of the lumen 28about an entire outer periphery of the plunger 12.

The plunger 12 includes a distal end 18. The distal end 18 can includeone or more blunt surfaces 74. In one embodiment, the blunt surfaces 74are generally planar at least before the distal end 18 contacts a curvedsurface 10 of the hollow tube 2. In one embodiment, the blunt surfaces74 can be angled transverse to the longitudinal axis of the plunger 12.For example, in one embodiment, one or more of the blunt surfaces 74 areoriented at an angle of between approximately 30° and 60° relative tothe longitudinal axis of the plunger 12. In one embodiment, andreferring now to FIG. 15, the distal end 18 can include a first bluntsurface 74A and a second blunt surface 74B. In one embodiment, the firstblunt surface 74A has a greater surface area than the second bluntsurface 74B. Additionally, or alternatively, the first blunt surface 74Acan be oriented toward the opening 7 of the hollow tube 2. In oneembodiment, the blunt surfaces 74 can be substantially orthogonallyarranged to one other.

Referring now to FIG. 14, opposing surfaces 78 of the distal end 18 canbe tapered to be rounded or bullet-shaped. In one embodiment, theopposing surfaces 78 are substantially symmetric. The opposing surfaces78 facilitate movement of bone graft material out of the lumen 28 of thehollow tube 2. Additionally, the opposing surfaces 78 allow the distalend 18 to move at least partially out of the opening 7 of the hollowtube 2, as generally illustrated in FIG. 17 during bone graft deliveryto a surgical site.

In one embodiment, the distal end 18 of the plunger 12 (or a portion ofthe plunger 12) can be adapted to bend or flex as the plunger 12 isadvanced proximate to the distal end 8 of the hollow tube 2. Morespecifically, in one embodiment, the plunger distal end 18 is configuredto bend relative to a longitudinal axis of the plunger 12, as generallyillustrated in FIG. 17. In this manner, the distal end 18 of the plungeris configured to push substantially all of the bone graft out of theopening 7 of the hollow tube 2.

In one embodiment, the plunger's distal end 18 is configured to bend inresponse to contact with an interior surface of the hollow tube 2. Forexample, the hollow tube 2 can have a geometry configured to bend atleast the distal end 18 of the plunger 12 toward the opening 7 of thehollow tube 2. In one embodiment, the hollow tube 2 includes a curvedsurface 10. The curved surface 10 is configured to deflect or bend theplunger distal end 18 from an alignment generally parallel to alongitudinal axis of the plunger 18 (as generally illustrated in FIG.16) to a bent position generally transverse to the longitudinal axis andtoward the opening 7 (as generally illustrated in FIG. 17). The bluntsurface 74 of the plunger 12 is configured to advance along the curvedsurface 10 without catching or sticking. In one embodiment, the secondblunt surface 74B is configured to contact the curved surface 10.Accordingly, the second blunt surface 74B can be oriented to slide alongthe curved surface 10. Additionally, or alternatively, the first bluntsurface 74A may not contact the curved surface 10. In contrast, aplunger 12 with a distal end 18 perpendicular to the plunger 12'slongitudinal axis would be expected to bind or catch on the curvedsurface 10 and prevent efficient discharge of bone graft from the hollowtube 2.

The curved surface 10 can be similar to a ramp or arch. Optionally, thecurved surface 10 includes surfaces generally opposite the opening 7.More specifically, the curved surface can be formed on side of the lumenlongitudinal axis opposite to the opening 7. In one embodiment, thecurved surface 10 has a length generally parallel to the longitudinalaxis of the hollow tube 2 that is approximately one-half of the maximumlength of the opening 7 parallel to the longitudinal axis.

The curved surface 10 is configured to interface with the distal end 18of the plunger 12 to alter the path of the plunger distal end.Additionally, the curved surface 10 can direct the bone graft materialaway from the opening 7 into a surgical site, such as a disc space. Morespecifically, the curved surface 10 can be configured to function as areverse funnel to disperse bone graft material ejected from the opening7 as generally illustrated in FIG. 9A.

In various embodiments, the plunger 12 is made of a flexible material,including, but not limited to. a rubber, an elastomeric material, othersuitable flexible materials and/or a combination of such materials. Thedistal end 18 can be made of a material different than the rest of theplunger 12. In one embodiment at least the distal end 18 of the plunger18 is made of the flexible material.

In various embodiments, the plunger distal end 18 has an area offlexibility 80 (see FIGS. 13-15). The area of flexibility 80 isconfigured to cause at least the distal end 18 to bend in apredetermined direction toward the opening 7. In one embodiment, thearea of flexibility 80 comprises one or more relief areas 82 formed inthe distal end 18. In one embodiment, the relief areas comprise notches82. In one embodiment, the notches 82 are formed transverse to alongitudinal axis of the plunger 12. In one embodiment, the notches 82are positioned to face the opening 7 when the plunger 12 is positionedwithin the hollow tube 2. Alternatively, the notches 82 can be orientedto face away from the opening 7.

In various embodiments, the notches 82 are formed such that wallsbetween adjacent notches have outer ends 84 that are generally planar.In one embodiment, the notches 82 extend at least approximately halfwaythrough the width 88 of the plunger. In one embodiment, the notches 82are spaced substantially evenly along the distal end 18. In oneembodiment, the notches 82 have a generally uniform size and shape. Inan alternate embodiment, the notches 82 have different sizes and/orshapes.

In one embodiment, the area of flexibility 80 is back cut to decreasethe width 88B of the plunger distal end 18. In one embodiment, thedistal end 18 is back cut to form a rabbet 86. In another embodiment,the rabbet 86 is formed on a side of the plunger 12 that is opposite tothe relief areas.

In one embodiment, the rabbet 86 extends generally parallel to alongitudinal axis of the plunger 12. Accordingly, in one embodiment, thedistal end 18 can have a width 88B that is less than a width 88A ofanother portion of the plunger 12, as generally illustrated in FIG. 15.The rabbet 86 has a depth selected to form a gap 90 between the distalend 18 and an interior of the lumen 28 such as shown in FIG. 16. In oneembodiment, the gap 90 beneficially prevents the plunger distal end 18from contacting and binding against the interior of the lumen 28 as thedistal end 18 bends toward the opening. For example, when the plunger 18contacts the curved surface 10 of the hollow tube 2, the plunger 12 maybuckle or bulge. The gap 90 provides clearance between the plunger 12and the hollow tube 2 if the plunger 12 buckles.

In various embodiments, the plunger 12 can include a plurality of teethand notches that are the same as, or similar to, the teeth and notches27 of the plunger described in conjunction with FIG. 7A. The notches canbe engaged by a means for advancing bone graft material describedherein. In this manner, the advancing means can move the plunger 12relative to the hollow tube 2. In various embodiments, the advancingmeans includes a ratchet, a gear, a worm gear with a helical thread andthe like such as described herein.

In one embodiment, the funnel 30 is releasably interconnected to aproximal end 6 of the hollow tube 2 to facilitate loading of bone graftmaterial into the opening 4. Thereafter, the funnel 30 is removed toimprove visualization of the distal end 8 and opening 7 in a surgicalsite. The funnel 30 can be the same as other funnels 30 describedherein.

In one embodiment, the graft delivery device 1 includes at least onevent port to release air from the lumen 28 as bone graft material isadvanced to the distal end 8 for discharge out of the opening 7.Although the vent port is not illustrated in FIGS. 10-17 for clarity,the vent port can be as the same as described in other embodiments ofthe graft delivery device described herein. For example, the vent ports21 described in conjunction with FIG. 7A can be used with the graftdelivery device 1 illustrated in FIGS. 10-17.

In some embodiments, indicia is formed on one or more surface of thehollow tube 2. The indicia can be the same as or similar to the indicia29 described in conjunction with FIG. 7. The indicia are configured toindicate a depth of insertion of the distal end 8 of the hollow tube 2into a surgical site. The indicia can include markings and numerals. Invarious embodiments, one or more of the indicia is radiopaque. Invarious embodiments, the indicia extends along the entire length of thehollow tube 2, or along a predetermined portion of the length.

In one embodiment, the hollow tube 2 can receive a fusion cage 60 of anembodiment of the present invention. The fusion cage 60 can have a fixedheight or be expandable after placement in a disc space. The fusion cage60 can have an opening 65 to discharge bone graft material therethrough.The opening 65 can be alignable with the opening 7 of the hollow tube 2.The fusion cage 65 can have a distal end 64 that is blunt, tapered, orwedge shaped. The hollow tube 2 can be configured to interconnect toother fusion cages.

In various embodiments, the hollow tube 2 is made of a flexible,semi-rigid, or rigid material including, but not limited to, one or moreof a plastic, a composite, a metal. In one embodiment, the hollow tube 2is formed of polycarbonate resin thermoplastic. In one embodiment, atleast a portion of the hollow tube 2 is radiopaque. In one embodiment,at least the distal end 8 is radiopaque or includes radiopaque markers,such as indicia 29 describe herein. In one embodiment, the hollow tube 2is substantially rigid. In one embodiment, at least a portion of thehollow tube 2 is flexible. For example, in one embodiment, at leastabout one-half of the hollow tube 2 comprising the distal end 8 isflexible. In one embodiment, the hollow tube 2 is generally linear.

In one embodiment, the hollow tube 2 is made of a substantiallytransparent or translucent material, and the hollow tube is not opaque.In one embodiment, at least a portion of the hollow tube 2 istransparent or translucent. In one embodiment, the hollow tube 2includes windows of a transparent or translucent material. Accordingly,in some embodiments, the plunger 12 is at least partially visible withinthe lumen 28 of the hollow tube 2. In various embodiments, the hollowtube 2 includes one or more image sensing device(s), such as anendoscope, camera, and/or an image sensor. The image sensing device(s)can be the same as or similar to the image sensing device(s) 36described in conjunction with FIG. 7D. In various embodiments, the imagesensing device(s) is removably or permanently coupled to the hollow tube2. In one embodiment, the image sensing device(s)is oriented to view atleast the distal end 8 of the hollow tube 2. Additionally, oralternatively, the image sensing device(s) is configured to view aninternal aspect of a disc space 172A. Embodiments of the graft deliverydevice 1 illustrated in FIGS. 10-17 can also be used by a surgeon torepair a collapsed/injured vertebrae, in the same ways as discussedabove in connection with the graft delivery device of FIGS. 1-7G.Referring now to FIGS. 18-25, a graft delivery device 1 of anotherembodiment of the present disclosure is generally illustrated. The graftdelivery device 1 includes features that are the same as or similar toother graft delivery devices described herein including those describedin conjunction with FIGS. 1-7G, 9A, 9B and 10-17. Notably, the graftdelivery device generally includes a cannular or hollow tube 2, aplunger 12, and a detachable funnel 30.

The hollow tube 2 is the same as, or similar to, other embodiments ofhollow tubes of the present disclosure. Accordingly, the hollow tube 2generally includes an opening 4 at a proximal end 6. The opening 4provides access to a substantially hollow interior formed between theproximal end 6 and the distal end 8. The hollow interior defines a lumen28 that extends through the hollow tube 2.

The lumen 28 has a predetermined cross-sectional shape. In variousembodiments, the cross-sectional shape of the lumen is round, ovoid,square, or rectangular. In another embodiment, the interior of the lumenis not round and is, for example, rectangular. In one embodiment thecross-sectional shape of the lumen 28 is substantially uniform along thelength of the hollow tube 2. In one embodiment, the lumen 28 has auniform cross-sectional size along its length. In various embodiments,the exterior of the hollow tube 2 has a shape that is one of round,ovoid, square, and rectangular.

In various embodiments, the distal end 8 of the hollow tube 2 is roundedor smooth. In one embodiment, the distal end has a wedge-shape.

In various embodiments, two discharge openings 7 are formed in thedistal end 8 of the hollow tube 2. In one embodiment, the dischargeopenings 7 are positioned transverse to a longitudinal axis of thehollow tube 2. More specifically, in one embodiment a first dischargeopening 7A can be formed in a first side 3A of the hollow tube 2 and asecond discharge opening 7B can be formed in a second side 3B. In oneembodiment, the openings 7 can extend to top and bottom surfaces 5A, 5Bof the hollow tube 2 as generally illustrated in FIGS. 19-20. In oneembodiment, generally illustrated in FIG. 20, the sides 3A, 3B of thehollow tube 2 do not extend past a proximal portion of the openings 7A,7B. As shown in FIG. 20, because the openings 7A, 7B of one embodimentextend to the top and bottom surfaces 5A, 5B, the distal end 8 can havea width 70B that is less than a width 70A of a proximal portion of thehollow tube 2.

Forming the openings 7A, 7B in this manner can facilitate the movementof bone graft material laterally out of the hollow tube 2. Morespecifically, by extending the openings in the inferior and superiordirections to the top and bottom surfaces 5A, 5B, the size of each ofthe openings 7A, 7B is increased. This feature minimizes the amount ofhorizonal travel (or turning) of bone graft as it moves from the lumen28 and is discharged out of the openings 7A, 7B. Further, bone graftmaterial flowing in the lumen 28 to the openings 7A, 7B does not have tochange direction or move vertically around an edge of the openings, suchas would occur if the openings were only formed in the first and secondsides 3A, 3B. For example, the openings 7A, 7B of the embodimentgenerally illustrated in FIGS. 19-20 does not include any obstructionsformed by portions of the first or second sides 3A, 3B extendinginwardly from at least one of the top surface 5A and the bottom surface5B. Because of this, one or more of the openings 7A, 7B can extend theentire height of lumen 28 from the top surface 5A to the bottom surface5B. Accordingly, there are no obstructions extending from the top andbottom surfaces 5A, 5B around which the bone graft material must flow oragainst which the bone graft material could become compacted orcompressed thereby impeding the flow of bone graft material from theopenings 7A, 7B.

The applicant has found that in this manner, less dense bone graftmaterial, such as bone graft that has a fibrous composition similar tothe consistency of a cotton ball, can be discharged laterally out of theopenings 7A, 7B. In contrast, some prior art bone graft delivery devicescannot be used to discharge fibrous bone graft laterally because thefibrous bone graft will compact and does not move out of the prior artdelivery devices. Additionally, the fibrous bone graft can catch onedges of openings of some prior art delivery devices.

The hollow tube 2 is configured to receive the plunger 12 of the presentdisclosure within the lumen 28, as illustrated in FIG. 18. The plunger12 can be used to push bone graft material positioned in the lumen 28out of the openings 7A, 7B at the distal end 8. In one embodiment, astop 16A can be formed on the plunger 12 to engage the proximal end 6 ofthe hollow tube 2. In this manner, the stop 16A prevents theover-insertion of the plunger 12 within the lumen 28.

The plunger 12 is generally configured to substantially conform to innerwalls of the lumen 28. Specifically, in one embodiment, at least aportion of plunger 12 has a cross-sectional shape which generallycorresponds to the interior shape of the lumen 28. In variousembodiments, the plunger 12 has a cross section that is round, ovoid,square, or rectangular. In one embodiment, a cross section of theplunger 12 is not round. In another embodiment, at least a portion ofthe plunger 12 is configured to contact the inner walls of the lumen 28about an entire outer periphery of the plunger 12.

Referring now to FIGS. 21-23, the plunger 12 includes a distal end 18.The distal end 18 can include one or more blunt surfaces 74. In oneembodiment, the blunt surfaces 74 are generally planar at least beforethe distal end 18 contacts a curved surface 10 of the hollow tube 2. Invarious embodiments, the blunt surfaces 74 are angled transverse to thelongitudinal axis of the plunger 12. For example, in one embodiment, oneor more of the blunt surfaces 74 are oriented at an angle of betweenapproximately 30° and 60° relative to the longitudinal axis of theplunger 12. In one embodiment, and referring now to FIG. 23, the distalend 18 includes first blunt surfaces 74A and second blunt surfaces 74B.In one embodiment, the first blunt surfaces 74A have a greater surfacearea than the second blunt surfaces 74B. Additionally, or alternatively,the first blunt surfaces 74A can be oriented toward the openings 7 ofthe hollow tube 2. In one embodiment, the first blunt surfaces aresubstantially orthogonally arranged to the second blunt surfaces.Referring now to FIG. 22, in one embodiment, opposing surfaces 78 of theplunger distal end 18 are tapered to form a rounded or bullet shapeddistal end 18. In one embodiment, the opposing surfaces 78 aresubstantially symmetric. The opposing surfaces 78 facilitate movement ofbone graft material out of the lumen 28 of the hollow tube.Additionally, the opposing surfaces 78 allow the distal end 18 to moveat least partially out of the openings 7A, 7B of the hollow tube 2during bone graft delivery to a surgical site, as generally illustratedin FIG. 25.

In one embodiment, the distal end 18 of the plunger 12 (or portions ofthe plunger 12) are adapted to bend or flex as the plunger is advancedproximate to the distal end 8 of the hollow tube 2. More specifically,in one embodiment, the plunger distal end 18 is bifurcated into a firstarm 94A and a second arm 94B by a groove 92 (see FIG. 24). The arms 94are configured to bend relative to a longitudinal axis of the plunger asgenerally illustrated in FIG. 25. In this manner, the distal end 18 ofthe plunger is configured to push substantially all of the bone graftmaterial out of the openings 7A, 7B of the hollow tube 2.

In one embodiment, the arms 94 are configured to bend in response tocontact with an interior surface of the hollow tube 2. For example, inone embodiment, the hollow tube 2 has a geometry configured to bend atleast the arms 94 of the distal end 18 of the plunger 12 toward theopenings 7A, 7B of the hollow tube 2.

In one embodiment, the hollow tube 2 includes an interior ramp 9. Theramp 9 is configured to interface with the distal end 18 to alter thepath of the plunger arms 94. More specifically, the ramp 9 includessurfaces 9A, 9B configured to deflect or bend the plunger arms 94 froman alignment generally parallel to a longitudinal axis of the plunger(as generally illustrated in FIG. 24) to a bent or deflected positiongenerally transverse to the longitudinal axis and toward the respectivefirst and second openings 7A, 7B (as generally illustrated in FIG. 25).Additionally, the ramp 9 can be used to direct the bone graft materialaway from the openings 7A, 7B into a surgical site, such as a discspace. In this manner, the ramp 9 can function as a reverse funnel todisperse bone graft material ejected from the opening(s) 7 as generallyillustrated in FIG. 9A.

In one embodiment, the ramp 9 comprises ramp surfaces 9A, 9B. In oneembodiment, the ramp surfaces 9A, 9B are symmetrically positioned abouta longitudinal axis of the hollow tube 2. In various embodiments, theramp surfaces 9A, 9B are of curvilinear or a arcuate shape. The rampsurfaces 9A, 9B beneficially urge bone graft material, when disposedwithin the hollow tube 2, to substantially exit the openings 7A, 7B.

Further, the ramp surfaces 9A, 9B are configured to engage one or moreblunt surfaces 74A, 74B of the plunger 12 to deflect or bend the arms 94away from the longitudinal axis of the plunger 12 and toward theopenings 7A, 7B of the hollow tube 2. In one embodiment, the bluntsurfaces 74A, 74B of the plunger 12 are configured to advance along theramp surfaces 9A, 9B without catching or sticking. In one embodiment,the second blunt surfaces 74B are configured to contact respective rampsurfaces. Accordingly, the second blunt surfaces 74B can be oriented toslide along the ramp surfaces 9A, 9B. Additionally, or alternatively,the first blunt surface 74A may not contact the ramp surfaces 9A, 9B. Incontrast, a plunger with a distal end 18 perpendicular to the plungerlongitudinal axis would be stopped by the ramp 9 which would preventefficient discharge of bone graft from the hollow tube 2.

In one embodiment, the ramp 9 extends from a closed portion of thedistal end 8 of the hollow tube 2 toward the proximal end 6 of thehollow tube 2. In one embodiment, the ramp 9 has a length parallel tothe longitudinal axis of the hollow tube 2. In various embodiments, thelength of the ramp 9 is at least approximately one-third, or aboutone-half, a length of the openings 7A, 7B. The ramp 9 can also providestructural support for the hollow tube 2. More specifically, byextending the ramp 9 toward the proximal end 6 of the hollow tube 2, theramp 9 provides support for the top and bottom surface 5A, 5B of thehollow tube 2. In various embodiments, the plunger 12 is made of aflexible material, including, but not limited to a rubber, anelastomeric material, other suitable flexible materials and/or acombination of such materials. In one embodiment, the distal end 18 ismade of a material different than the rest of the plunger 12. In oneembodiment at least the distal end 18 of the plunger 18 is made of theflexible material.

In various embodiments, the plunger distal end 18 has one or more areasof flexibility 80 (i.e., 80A, 80B) (see FIGS. 21-23). The areas offlexibility 80 are configured to allow at least the arms 94 to bend in apredetermined direction toward the openings 7A, 7B. In one embodiment,the areas of flexibility 80 comprise relief areas 82 formed in thedistal end 18. In one embodiment, the relief areas comprise notches 82.In one embodiment, the notches 82 are formed transverse to alongitudinal axis of the plunger 12. In one embodiment, the notches 82are positioned to face the openings 7 when the plunger 12 is positionedwithin the hollow tube 2. Alternatively, the notches 82 can be orientedto face away from the openings, such as toward the groove 92 between thearms 94. In various embodiments, the notches 82 are formed such thatwalls between adjacent notches have outer ends 84 that are generallyplanar. Additionally, or alternatively, the notches 82 extend at leastapproximately halfway through the width of the arms 94. In oneembodiment, the notches 82 are spaced substantially evenly along thedistal end 18. In one embodiment, the notches 82 have a generallyuniform size and shape. In an alternate embodiment, the notches 82 havedifferent sizes and/or shapes.

In one embodiment, the area of flexibility 80 is back cut to decreasethe width 88B of the plunger distal end 18. In one embodiment, thedistal end 18 is back cut to form one or more rabbets 86. In anotherembodiment, the rabbet 86 is formed on sides of the plunger 12 with therelief areas.

In one embodiment, the rabbets 86 extend generally parallel to alongitudinal axis of the plunger 12. Accordingly, in one embodiment, thedistal end 18 can have a width 88B that is less than a width 88A ofanother portion of the plunger 12 as generally illustrated in FIG. 23.The rabbets 86 can have a depth selected to form gaps 90 between thedistal end 18 and an interior of the lumen 28 such as shown in FIG. 24.More specifically the width 88B of the distal end can be less than aninterior width of the lumen 28. In one embodiment, the gaps 90beneficially prevent the plunger arms 94 from contacting and bindingagainst the interior of the lumen 28 as the arms bend toward theopenings. For example, when the plunger 18 contacts the curved surfacesof the ramp 9 of the hollow tube 2, the arms 94A, 94B may buckle orbulge at least slightly. The gaps 90 provides clearance between theplunger 12 and the hollow tube 2 if the arms 94A, 94B buckle.

In various embodiments, the plunger 12 includes a plurality of teeth andnotches that are the same as, or similar to the teeth and notches 27 ofthe plunger described in conjunction with FIG. 7A. The notches can beengaged by a means for advancing bone graft material described herein.In this manner, the advancing means can move the plunger 12 relative tothe hollow tube 2. In various embodiments, the advancing means comprisea ratchet, a gear, a worm gear with a helical thread and the like, suchas described herein.

In one embodiment, the funnel 30 is releasably interconnected to aproximal end 6 of the hollow tube 2 to facilitate loading of bone graftmaterial into the opening 4. Thereafter, the funnel 30 can be removed toimprove visualization of the distal end 8 and opening 7 in a surgicalsite. The funnel 30 can be the same as one or more other funnels 30 ofthe present disclosure.

In various embodiments, the graft delivery device 1 includes at leastone vent port to release air from the lumen 28 as bone graft material isadvanced to the distal end 8 for discharge out of the openings 7.Although the vent port is not illustrated in FIGS. 18-25 for clarity,the vent port can be as described in other embodiments of the graftdelivery device described herein. For example, the vent ports 21described in conjunction with FIG. 7A can be used with the graftdelivery device 1 illustrated in FIGS. 18-25.

In various embodiments, indicia is formed on one or more surface of thehollow tube 2. The indicia can be the same as or similar to the indicia29 described in conjunction with FIG. 7. The indicia are configured toindicate a depth of insertion of the distal end 8 of the hollow tube 2into a surgical site. The indicia can include markings and numerals. Invarious embodiments, one or more of the indicia is radiopaque. Invarious embodiments, the indicia extends along the entire length of thehollow tube 2, or along a predetermined portion of the length.

In one embodiment, the hollow tube 2 can receive a fusion cage 60 of anembodiment of the present invention. The fusion cage 60 can have a fixedheight or be expandable after placement in a disc space. The fusion cage60 can have at least one opening 65 to discharge bone graft materialtherethrough. The opening 65 can be alignable with the openings 7 of thehollow tube 2. The fusion cage 65 can have a distal end 64 that isblunt, tapered, or wedge shaped. The hollow tube 2 can be configured tointerconnect to other fusion cages.

In various embodiments, the hollow tube 2 is made of a flexible,semi-rigid, or rigid material including one or more of a plastic, acomposite, a metal. In one embodiment, the hollow tube 2 is formed ofpolycarbonate resin thermoplastic. In various embodiments, at least aportion of the hollow tube 2 is radiopaque. In one embodiment, at leastthe distal end 8 is radiopaque or includes radiopaque markers, such asindicia 29 describe herein.

In one embodiment, the hollow tube 2 is substantially rigid. Optionally,at least a portion of the hollow tube 2 may be flexible. For example, inone embodiment, at least about one-half of the hollow tube 2 comprisingthe distal end 8 is flexible. In one embodiment, the hollow tube 2 isgenerally linear.

In one embodiment, the hollow tube 2 is made of a substantiallytransparent or translucent material, and the hollow tube is not opaque.In one embodiment, at least a portion of the hollow tube 2 istransparent or translucent. In one embodiment, the hollow tube 2includes windows of a transparent or translucent material. Accordingly,in some embodiments, the plunger 12 is at least partially visible withinthe lumen 28 of the hollow tube 2

In various embodiments, the hollow tube 2 includes one or more imagesensing device(s), such as an endoscope, camera, and/or an image sensor.The image sensing device(s) can be the same as or similar to the imagesensing device(s) 36 described in conjunction with FIG. 7D. In variousembodiments, the image sensing device(s) is removably or permanentlycoupled to the hollow tube 2. In one embodiment, the image sensingdevice(s)is oriented to view at least the distal end 8 of the hollowtube 2. Additionally, or alternatively, the image sensing device(s) isconfigured to view an internal aspect of a disc space 172A.

Embodiments of the graft delivery device 1 illustrated in FIGS. 18-25can also be used by a surgeon to repair a collapsed/injured vertebrae,in the same ways as discussed above in connection with the graftdelivery device of FIGS. 1-7G.

Referring now to FIG. 26, another embodiment of an integrated fusioncage 60 and graft delivery device 1 of the present disclosure isillustrated. The integrated device 1 generally includes a hollow tube 2,a fusion cage 60, and a means for advancing bone graft material throughthe hollow tube. In various embodiments, the advancing means includesthe use of manual force, mechanical force, electric force, pneumaticforce, or any other force to advance bone graft material through thehollow tube 2. In one embodiment, a user can manipulate the integrateddevice 1 with a single hand. This beneficially frees the user's otherhand for other action.

In one embodiment, the advancing means includes a handle or grip 304.The grip 304 is operable to selectively move bone graft material throughthe lumen of the hollow tube 2 for discharge from an opening 7 at thetube distal end 8.

The hollow tube 2 includes a proximal end 6 configured to releasablyinterconnect to the grip 304. Bone graft material can be positionedwithin the lumen of the hollow tube 2, such as with a funnel 30(illustrated in FIG. 7B). The funnel 30 may then be removed from theproximal end 6. The proximal end 6 can then be interconnected to thegrip 304. Optionally, the hollow tube 2 can be used to eject bone graftmaterial into a surgical site without being affixed to the grip 304.

In various embodiments, the grip 304 frictionally engages the tubeproximal end 6. In various embodiments, the hollow tube 2 or the grip304 includes a lock or a latch to secure the hollow tube 2 to the grip304. In another embodiment, a portion of the hollow tube 2 canthreadably engage the grip 304. In another embodiment, the proximal end6 and grip 304 are interconnected with a bayonet mount. In still anotherembodiment, the grip 304 includes a knob 310 such that the hollow tube 2can be selectively interconnected to the grip 304. Other means ofinterconnecting the hollow tube 2 to the grip 304 are contemplated.

A channel 324 is formed through the grip 304. The channel 324 includes aproximal opening 326 and extends through the grip 304 and the knob 310.In one embodiment, the opening 326 is configured to receive a plunger12. The plunger 12 can extend through the channel 324 into a hollow tube2 interconnected to the grip 304.

The grip 304 includes a means for advancing bone graft material throughthe lumen 28 of the hollow tube 2 (i.e., the lumen 28 as shown in FIGS.12 and 20). In one embodiment, the advancing means comprises acompressed fluid. Specifically, in one embodiment, the grip 304 isconfigured to advance the bone graft material using the compressedfluid, such as air. Manipulating the grip trigger 306 can releasecompressed fluid into the proximal end 6 of the lumen. In oneembodiment, the hollow tube includes a single vent port 21B at thedistal end. When a proximal end of bone graft material within the lumenreaches the vent port 21B, the compressed fluid is released from thelumen. In this manner, the fluid is not introduced into the surgicalsite.

In one embodiment, a pusher 18A is positioned in the lumen 28 of thehollow tube 2 after the lumen is loaded with bone graft material. Thepusher 18A may be similar to the distal end 18 of a plunger 12, such asgenerally illustrated in FIG. 7A. Regardless, the pusher 18A isconfigured to substantially conform to interior surfaces of the lumen28. In this manner, the pusher 18A prevents the fluid from beingdischarged from the opening 7 into the surgical site.

When a pressurized fluid is introduced into the lumen 28 behind thepusher 18A, the pusher advances toward the distal end 8. The bone graftmaterial is urged toward the distal end 8 and through the opening 7 bythe pusher 18A. In one embodiment, when a proximal end of the pusher 18Aadvances past the vent port 21B, the compressed fluid is released fromthe lumen 28 and the pusher 18A stops. Alternatively, the pusher maystop advancing by contact with an interior ramp 9 within the hollow tube2.

In another embodiment, the means for advancing the bone graft materialcomprises a plunger 12. Accordingly, in one embodiment, the grip 304 isconfigured to selectively advance a plunger 12 through the lumen 28 toadvance the bone graft material. The grip 304 is configured to advancethe plunger 12 axially with respect to the lumen 28 of the hollow tube2. Specifically, the grip 304 can manipulate the plunger 12 such that adistal end of the plunger 12 opposite the plunger handle 16 movestowards the distal end 8 of the hollow tube 2. The grip 304 isconfigured to manually or automatically apply a force to the plunger 12.In various embodiments, the force is generated by one or more of a user,a motor, a compressed fluid, or any other means of generating a force.

In various embodiments, the plunger 12 includes teeth, notches 27, ordepressions which are engageable by the grip 304 to axially adjust theposition of the plunger 12. The notches 27 can be substantially evenlyspaced along the plunger 12.

In one embodiment, a motor is positioned within the grip 304 to advancethe plunger 12. In one embodiment, the motor is operable to rotate ashaft. The shaft may include a gear to translate the rotational movementinto a linear movement of the plunger 12. In one embodiment, the gearincludes teeth to engage the notches 27 or teeth of the plunger 12. Abattery can provide power to the motor. In one embodiment, the batteryis housed in the grip 304.

In various embodiments, the grip includes a gear or a ratchet configuredto engage teeth, notches 27, or depressions on the plunger 12.Specifically, in one embodiment, the ratchet of the grip 304 isconfigured to engage the plurality of notches 27 formed in the plunger12. In one embodiment, the channel 324 of the grip 304 includes anaperture or window through which a portion of the gear or ratchet canextend to engage the plunger 12.

In one embodiment, when activated, the ratchet engages a first notch andthen a second notch to incrementally advance the plunger 12 distallywithin the hollow tube 2. Bone graft material within the hollow tube 2is then pushed by the plunger 12 toward the distal end 8 of the hollowtube 2. Ratcheting mechanisms that can be used with the grip 304 areknown to those of skill in the art. Some examples of ratchetingmechanisms are described in U.S. Pat. App. Pub. 2002/0049448, U.S. Pat.App. Pub. 2004/0215201, U.S. Pat. App. Pub. 2009/0264892, U.S. Pat. Nos.7,014,640, 8,932,295, 9,655,748, and 9,668,881 which are eachincorporated herein by reference in their entirety.

In various embodiments, the grip 304 is configured to discharge apredetermined amount of bone graft material each time the plunger 12 isincrementally advanced within the hollow tube 2. In one embodiment,between about 0.25 and 1.0 cc of bone graft material is discharged fromthe distal end 8 of the hollow tube 2 each time the plunger is advanced.In another embodiment, between about 0.25 and 1.0 cc of bone graftmaterial is discharged is discharged each time the trigger 306 isactuated by a user.

In one embodiment, the grip 304 is configured to enable vision of asurgical sight by a user. Specifically, the grip 304 may besubstantially even with one or more surfaces 3, 5 of the hollow tube 2.In this manner, in one embodiment, the grip 304 does not obstruct a lineof sight along at least one surface 3, 5. In another embodiment, anexterior surface of the grip 304 is about even with a plane defined byone of the side surfaces 3. Additionally, or alternatively, an upperportion of the grip 304 does not extend beyond a plane defined by a topsurface 5 of the hollow tube. Optionally, a window or view port isformed in the grip 304 to allow view of the distal end 8 of the hollowtube 2.

In various embodiments, the integrated fusion cage and graft deliverydevice 1 includes a visualization system. In various embodiments, thevisualization system includes (but is not limited to) one or more of acamera, a light, an endoscope, and a display. In various embodiments,the visualization system is permanently or removably affixed to theintegrated fusion cage and graft delivery device 1. In one embodiment,the visualization system is affixed to the hollow tube 2.

In one embodiment, the grip 304 includes a motor or other actuator whichcan be manipulated by a user to advance or withdraw the plunger in thehollow tube 2. The motor or actuator can operate the ratchet.

In various embodiments, the grip 304 is manually manipulated by a userto move the plunger 12. In one embodiment, the grip 304 includes atrigger 306. In various embodiments, the trigger 306 is hinged orpivotally interconnected to the grip 304. When the trigger 306 isactuated by a user, the plunger 12 is advanced in the hollow tube 2.

In one embodiment, actuating the trigger 306 included pulling thetrigger toward a handle 308 of the grip. In one embodiment, the trigger306 is biased away from the handle 308, as generally illustrated in FIG.26. Pulling the trigger 306 toward the handle 308 causes the ratchet toengage the plunger 12. The ratchet engages a notch 27 of the plunger 12and moves the plunger toward the distal end 8 of the hollow tube.Successively pulling the trigger 306 incrementally advances the plunger12 forward in the hollow tube 2.

In one embodiment, the ratchet is operably connected to an upper end ofthe trigger 306. In this embodiment, pulling the trigger 306 causes theratchet to move toward the hollow tube 2. In one embodiment, a lock pawl(not illustrated) is operably connected to the grip 304. The lock pawlcan engage a notch of the plunger 12 to prevent inadvertent movement ofthe plunger 12 distally.

The grip 304 is used to advance or withdraw the plunger 12. In oneembodiment, the grip 304 includes a switch 312 operable to change thedirection of movement of the plunger 12. By manipulating the switch 312,a user can cause the plunger 12 to advance into the hollow tube 2 or,alternatively, withdraw from the hollow tube 2. In one embodiment, towithdraw the plunger 12, the plunger handle 16 can be pulled away fromthe grip 304. In one embodiment, the switch 312 comprises a button.

In various embodiments, the grip 304 includes a loading port 314, asillustrated in FIG. 26. The loading port 314 provides access to thelumen of the hollow tube 2. In one embodiment, the loading port 314 isin fluid communication with the channel 324 through the grip 304.Accordingly, bone graft material can be added to the hollow tube throughthe loading port 314. In one embodiment, the loading port 314 isconfigured to engage a funnel 30 of any embodiment of the presentdisclosure. Additionally, or alternatively, a syringe 42 mayinterconnect to the grip 304 to discharge bone graft material 42 intothe lumen through the loading port.

Additionally, or alternatively, a capsule or package 316 of bone graftmaterial can be loaded into the lumen 28 through the loading port 314.The package 316 can include any type of bone graft material, includingone or more of: autogenous (harvested from the patient's own body),allogeneic (harvested from another person), and synthetic. Apredetermined amount of bone graft material can be included in thepackage 316. In one embodiment, each package includes between about 0.25and 1.0 cc of bone graft material. One or more packages 316 may beloaded into the lumen 28 to deliver a desired amount of bone graftmaterial to a surgical site.

Embodiments of the integrated infusion cage 60 and graft delivery device1 illustrated in FIG. 26 can also be used by a surgeon to repair acollapsed/injured vertebrae, in the same ways as discussed above inconnection with the graft delivery device of FIGS. 1-7G.

Referring now to FIG. 27, still another embodiment of an integratedfusion cage 60 and graft delivery device 1 of the present disclosure isillustrated. The device 1 illustrated in FIG. 27 is similar to thedevice 1 described in conjunction with FIG. 26 and includes many of thesame, or similar features. The integrated device 1 generally includes ahollow tube 2 configured to receive a fusion cage 60 and a means foradvancing bone graft material through the hollow tube for discharge outof an opening 65 of the fusion cage 60.

In one embodiment, the advancing means includes a grip 304. The grip 304is configured to interconnect to a hollow tube 2 of any embodiment ofthe present disclosure. The grip 304 is operable to selectively movebone graft material through the lumen 28 (not shown) of the hollow tube2 for discharge from the tube distal end 8. Bone graft material can bepositioned within the lumen while the hollow tube 2 is interconnected tothe grip 304.

In one embodiment, the grip 304 frictionally engages a predeterminedportion of the hollow tube 2. In various embodiments, the hollow tube 2or the grip 304 include a lock or a latch to secure the hollow tube 2 tothe grip 304. In one embodiment, the grip 304 engages at least the twoside surfaces 3 of the hollow tube 2. In one embodiment, the grip 304includes opposing flanges 320. One or more of the flanges 320 can bemoved inwardly toward the hollow tube 2, similar in operation to aclamp. In this manner, the flanges 320 can apply a compressive force tothe side surfaces 3 to interconnect the hollow tube 2 to the grip. Othermeans of interconnecting the hollow tube 2 to the grip 304 arecontemplated.

The grip 304 includes a means for advancing bone graft material throughthe lumen of the hollow tube 2. In one embodiment, the advancing meanscomprises a compressed fluid. Specifically, in one embodiment, the grip304 is configured to advance the bone graft material using thecompressed fluid, such as air. Manipulating the grip trigger 306 canrelease compressed fluid into the proximal end 6 of the lumen. When apressurized fluid is introduced into the lumen, the plunger 12 advancestoward the distal end 8. The bone graft material is urged toward thedistal end 8 and through the opening 65 by the plunger 12. In oneembodiment, the plunger 12 stops advancing by contact with an interiorramp within the hollow tube 2.

In another embodiment, the means for advancing the bone graft materialis configured to selectively advance the plunger 12 through the lumen toadvance the bone graft material. Specifically, the grip 304 isconfigured to manually or automatically apply a force to the plunger 12.In various embodiments, the force is generated by one or more of a user,a motor, a compressed fluid, or any other means of generating a force.

In one embodiment, a motor is positioned within the grip 304 to advancethe plunger 12. In one embodiment, the motor is operable to rotate ashaft. In one embodiment, the shaft includes a gear to translate therotational movement of the shaft into a linear movement of the plunger12. In one embodiment, the plunger includes notches to engage the gearof the shaft. In one embodiment, a battery provides power to the motor.In one embodiment, the battery is housed in the grip 304.

In various embodiments, the plunger 12 includes teeth, notches, ordepressions which are engageable by the grip 304 to axially adjust theposition of the plunger 12. In various embodiments, the grip includes agear or a ratchet configured to engage teeth or notches on the plunger12. Specifically, in one embodiment, the ratchet of the grip 304 isconfigured to engage a plurality of notches formed in the plunger. Inone embodiment, the notches are substantially evenly spaced along theplunger. The ratchet engages a first notch and then a second notch toincrementally advance the plunger distally within the hollow tube 2.Bone graft material within the hollow tube 2 is then pushed by theplunger 12 toward the distal end 8 of the hollow tube.

In one embodiment, the grip 304 is configured to enable vision of asurgical sight by a user. Specifically, in one embodiment, the grip 304does not extend above a top surface 5 of the hollow tube. In thismanner, in one embodiment, the grip 304 does not obstruction a line ofsight along at least the top surface 5. In another embodiment, lateralsurfaces of the grip are about even with a plane defined by one of theside surfaces 3 of the hollow tube.

In various embodiments, the grip 304 includes a motor or other actuatorwhich can be manipulated by a user to advance or withdraw the plunger 12in the hollow tube 2. The motor or actuator can operate the ratchet.

In various embodiments, the grip 304 is manually manipulated by a userto move the plunger 12. In one embodiment, the grip 304 includes atrigger 306. In various embodiments, the trigger 306 is hinged orpivotally interconnected to the grip 304. When the trigger 306 isactuated by a user, the plunger 12 advances in the hollow tube 2.Specifically, in one embodiment, the trigger 306 is functionallyinterconnected to the plunger 12.

In one embodiment, actuating the trigger 306 includes pulling thetrigger 306 toward a handle 308 of the grip 304. In one embodiment, thetrigger 306 is biased away from the handle 308, as generally illustratedin FIG. 27. In one embodiment, pulling the trigger 306 toward the handle308 causes the ratchet to engage the plunger 12. The ratchet engages anotch of the plunger 12 and moves the plunger 12 toward the distal end 8of the hollow tube 2. Successively pulling the trigger 306 incrementallyadvances the plunger 12 forward in the hollow tube 2.

In one embodiment, the ratchet is associated with an upper end of thetrigger 306. In this embodiment, pulling the trigger 306 causes theratchet to move toward the distal end of the hollow tube 2. In oneembodiment, a lock pawl (not illustrated) is operably connected to thegrip 304. In one embodiment, the lock pawl engages a notch of theplunger 12 to prevent the plunger 12 from moving distally.

The grip 304 is used to advance or withdraw the plunger 12. In oneembodiment, the grip 304 includes a switch operable to change thedirection of movement of the plunger 12. By manipulating the switch, auser can cause the plunger 12 to advance into the hollow tube 2 or,alternatively, withdraw from the hollow tube 2. In one embodiment, towithdraw the plunger 12, the plunger handle 16 is pulled away from thegrip 304.

In various embodiments, the grip 304 includes a knob 318. In oneembodiment, the knob 318 is configured to advance or withdraw theplunger 12 within the hollow tube 2. Specifically, rotating the knob 318in a first direction causes the plunger 12 to advance toward the distalend 8. Rotating the knob 318 in a second direction causes the plunger 12to withdraw away from the distal end 8.

In one embodiment, the knob 318 includes a gear, such as a pinion. Thegear includes teeth that engage notches or teeth extending linearlyalong the plunger 12, similar to a rack. Rotational movement of the knob318 is converted into linear motion of the plunger 12 by interactionbetween the knob pinion with the plunger rack.

In In various embodiments, the hollow tube 2 discharges a predeterminedamount of bone graft material associated with each rotation, or partialrotation of the knob 318. Specifically, a calibrated amount of bonegraft material may be discharged from the hollow tube 2 for eachquarter, half, or full rotation of the knob 318. In one embodiment, thehollow tube 2 is configured to discharge approximately 1 cc of bonegraft material for each half turn of the knob 318.

In one embodiment, the knob 318 is configured to provide tactilefeedback to a user after a predetermined amount of rotation. Forexample, when the knob 318 is rotated one or more of ⅛, ¼, ½, and 1turn, the knob 318 and/or the grip 304 may vibrate or provide othertactile feedback to the user.

The grip 304 is also operable to expand the fusion cage 60 and separatethe fusion cage 60 from the hollow tube 2. In one embodiment, the knob318 slides within a slot 322 to release the fusion cage 60. In oneembodiment, pulling the knob 318 away from the distal end 8 of thehollow tube 2 detaches the fusion cage 60.

Embodiments of the integrated infusion cage 60 and graft delivery device1 illustrated in FIG. 27 can also be used by a surgeon to repair acollapsed/injured vertebrae, in the same ways as discussed above inconnection with the graft delivery device of FIGS. 1-7G.

In one embodiment, a bone graft tamping device (not shown) is provided,and is adapted to be inserted into the hollow tube 2 after the plunger12 is removed from the hollow tube 2. The bone graft tamping device,according to this embodiment, may include one or more longitudinalchannels along the outer circumference of the bone graft packer forpermitting any trapped air to flow from the bone graft receiving area tothe graspable end of the hollow tube during packing of bone graft. Thebone graft packer may further include a handle at one end designedergonomically for improving ease of use. The bone graft packer in thisembodiment thereby facilitates packing of bone graft within the hollowtube.

In one embodiment, the hollow tube 2 is fitted with a passageway whereina surgical tube or other device may be inserted, such as to deliver aliquid to the surgical area or to extract liquid from the surgical area.In such an embodiment, the plunger 12 is adapted in cross-section toconform to the hollow tube's cross-section.

In another embodiment of the present invention, a kit of surgicalinstruments comprises a plurality of differently sized and/or shapedhollow tubes 2 and a plurality of differently sized and/or shapedplungers 12. Each of the plungers correspond to at least one of thehollow tubes, whereby a surgeon may select a hollow tube and a plungerwhich correspond with one another depending upon the size and shape ofthe graft receiving area and the amount or type of bone graft to beimplanted at such area. The corresponding hollow tubes and plungers areconstructed and arranged such that bone graft can be placed within thehollow tubes with the plungers, and inserted nearly completely into thehollow tubes for removing substantially all of the bone graft materialfrom the hollow tubes, such as in the preferred embodiments for theplunger described above. The use of more than one hollow tube/plungercombination permits at least two different columns of material to beselectively delivered to the targeted site, e.g. one of bone graftmaterial from the patient and another of Bone Morphogenetic Protein(BMP), or e.g. two different types of bone graft material or onedelivering sealant or liquid. Also, one or both hollow tubes could bepreloaded with bone graft material.

In various embodiments, the kit of surgical instruments comprises aplurality of differently sized and/or shaped graft retaining structures,each corresponding to at least one hollow tube and at least one plunger.

The bone graft receiving area can be any area of a patient that requiresdelivery of bone graft. In the preferred embodiment, the bone graft isdelivered in a partially formed manner, and in accordance with anotheraspect of the present invention, requires further formation afterinitial delivery of the bone graft.

Another embodiment of the present invention provides a method by which ahollow tube and a plunger associated with the hollow tube are providedto facilitate delivery of the bone graft to a bone graft receiving area.

According to one embodiment, the present invention provides a bone graftdelivery system, by which a hollow tube and/or plunger assembly areprepared prior to the surgical procedure on the patient begins, thusminimizing the overall impact of the grafting aspect of a surgicalimplantation or other procedure. In various embodiments, the hollow tube2 is made to be stored with bone graft in it for a period of time,whether the tube is made of plastic, metal or any other material.Depending upon the surgical application, it may be desirable to onlypartially fill the tube for storage, so that a plunger can be at leastpartially inserted at the time of a surgery.

In various embodiments, the integrated fusion cage 60 and graft deliverydevice 1 come with a pre-filled hollow tube 2 (i.e., with bone graft),or a non-filled hollow tube 2, in which the surgeon will insert bonegraft received from the patient (autograft), or from another humansource (allograft). In either case, the surgeon may first remove anywrapping or seals about the hollow tube 2, and/or the pre-filled bonegraft, and insert the hollow tube 2 into the patient such that thesecond end of the hollow tube is adjacent the bone graft receiving area.Once the hollow tube 2 is in place, and the opening at the second end ofthe hollow tube is oriented in the direction of the desired placement ofbone graft, the surgeon inserts the second end of the plunger 12 intothe opening at the first end of the hollow tube, and begins pressing thesecond end of the plunger against the bone graft material in the hollowtube. In this fashion, the plunger 12 and hollow tube 2 cooperatesimilar to that of a syringe, allowing the surgeon to steadily andcontrollably release or eject bone graft from the second end of thehollow tube as the plunger is moved farther and farther into the openingin the hollow tube. Once the desired amount of bone graft has beenejected from the hollow tube 2 (in some instances all of the bone grafthas been ejected from the hollow tube) the surgeon removes the plunger12 from the hollow tube, and completes the surgery. In certainoperations, the surgeon may elect to place additional bone graft intothe hollow tube, and repeat the steps described above. In oneembodiment, the pre-filled bone graft elements are color-coded toreadily identify the type of bone graft material contained therein.

According to the embodiment described in the preceding paragraph, thepresent invention may be carried out by a method in which access isprovided to a graft receiving area in a patient's body, bone graft isplaced into a hollow tube 2 having a first end and a second end, thehollow tube, together with the bone graft, is arranged so that the firstend of the hollow tube is at least adjacent to the graft receiving areaand permits lateral or nearly lateral (in relation to the longitudinalaxis of the hollow tube and plunger assembly) introduction of bone graftto the graft receiving area. This method prevents loss of bone graft dueto improper or limited orientation of the integrated fusion cage andgraft delivery device, and further allows a user to achieve insertion ofa desired quantity of bone graft by way of the contoured plunger andhollow tube configuration described according to preferred embodimentsherein.

In another embodiment, the method of the present invention is carriedout by providing a hollow tube 2 having a first end and a second end.The tube 2 is constructed so that it may receive a measurable quantityof bone graft, and so that the first end may be arranged at leastadjacent to a bone graft receiving area, and so that bone graft can bedelivered from the first end of the hollow tube through the second endof the hollow tube and eventually to the bone graft receiving area uponmovement of the plunger 12 in a generally downward direction through thehollow tube (i.e., in a direction from the first end to the second end).In one embodiment, a graft retaining structure is also provided for usein connection with the contoured edge of the plunger 12, such that thegraft retaining structure is positioned between the contoured edge ofthe plunger and the bone graft, but which is adhered to the bone graftand remains at the graft receiving area following removal from thehollow tube. In one embodiment, the bone graft is provided in discretepackages or containers. In another embodiment, this graft retainingstructure is employed with another tool, such as a graft packer, whichis employed either before or after the hollow tube is removed from thegraft receiving area.

In another embodiment, the one or more plungers 12 corresponding to theone or more hollow tubes 2 are positioned with distal ends near theproximate end of the horizontal tube before use. In one embodiment, theplungers have a detent to retain the plunger in ready position withoutundesired movement before the surgeon chooses which one or more plungersto extend through one or more hollow horizontal tube and deliver bonegraft material and/or desired material to the surgical area.

According to another embodiment of the present invention, a hollow tubeand plunger assembly is provided in which the hollow tube and/or theplunger assembly is disposable. Alternatively, the tube may be made of abiocompatible material which remains at least partially in the patientwithout impairing the final implantation. Thus, the hollow tube may beformed from a material that is resorbable, such as a resorbable polymer,and remain in the patient after implantation, so as not to interferewith the growth of the bone or stability of any bone graft or implant.

The current design of the graft delivery device 1 of the presentinvention preferably comprises a hollow tubular member comprising arounded edge rectangular shaft, which may be filled by the surgeonduring surgery, or is pre-filled with grafting material. The loading iscarried out by the plunger. The rectangular design is preferable as itallows the largest surface area device to be placed into the annulotomysite of a disc, but in other embodiments may be formed similar toconventional round shafts. The other preferred feature includes alaterally-mounted exit site for the graft material. The combination ofthis design feature allows direction-oriented dispersion of the graftmaterial. This allows ejection of the graft material into an empty discspace as opposed to below the hollow tube, which would tend to impactthe material and not allow its spread through a disc space.

Another feature of this design of the graft delivery device 1 of thepresent invention is that a rectangular design allows the user toreadily determine the orientation of the device and thereby thedirection of entry of the bone graft material into the surgical area. Inother embodiments, this feature may be achieved by exterior markings orgrooves on the exterior on the hollow tube. In various embodiments, suchexterior grooves or markings allow the use of a range of cross-sectionsfor the device, including a square, circle, or oval, while allowing auser to readily determine the orientation of the device relative to thedirection of entry of the bone graft material into the surgical area.

A further feature of this design of the graft delivery device 1 of thepresent invention is that an anti-perforation footing or shelf is placedon the bottom of the hollow tube to prevent annular penetration and/orinjury to the patient's abdomen or other anatomy adjacent the bone graftreceiving area.

In another embodiment of the present invention, all or some of theelements of the device or sections of all or some of the device may bedisposable. Disposable medical devices are advantageous as theytypically have reduced recurring and initial costs of manufacture.

In another embodiment of the device, the distal tip or end of theplunger device is composed of a different material to the rest of theplunger, so as the material at the distal end of the plunger issponge-like or softer-than or more malleable than the rest of theplunger so as upon engagement with the interior distal end of the hollowtube, the distal end of the plunger substantially conforms to theinterior configuration of the hollow tube. Similarly, the plunger distalend may be made of a material that is adaptable to substantially conformto the interior shape of the distal end of the hollow tube. Suchconfigurations enable substantially all of the material contained withinthe plunger to be delivered to the targeted site.

Another alterative embodiment of the design described herein includesnavigation aiding indicia 29 on one or more surfaces of the hollow tube2 (see, for example, FIG. 7B) to permit a surgeon to know how far thedevice 1 has been inserted or to ensure proper alignment relative to atransverse bone graft delivery site (i.e. disc space). Such capabilityis particularly important when the patient or surgical area is notpositioned immediately below the surgeon, or multiple procedures arebeing performed. Navigation aiding indicia allows more immediate andreliable locating of the surgical area for receiving of bone graftmaterial. In one embodiment, indicia 29 includes the hollow tube 2 beingscored or marked , or otherwise providing some affirmative indication,actively or passively, to the surgeon to indicate degree of delivery ofthe material, e.g. bone graft material, to the delivery site, and/orposition of the plunger 12. For example, the exterior of the hollow tube2 could be color-coded and/or provided with bars as the indicia 29. Inanother embodiment, a computer and/or electro-mechanical sensor ordevice is used to provide feedback to the surgeon to indicate degree ofdelivery of the material, e.g. amount of cc's of bone graft material, tothe delivery site, and/or position of the plunger element.

In another alterative embodiment to the design described herein, theplunger 12 includes an activation device, which is often in a liquid orsemi-liquid state, and that is injected once the semi-solid portion ofthe morphogenic protein has been displaced by the movement of theplunger 12 through the hollow tube 2. That is, the plunger 12 pushes thedry material, and once completed, has a bulb or other device on theusable end to insert the liquid portion of the activating agent throughthe inner lumen 28 within the plunger 12 to evacuate the liquid from theplunger and out an opening at the non-usable end of the plunger so as tocontact the dry material already inserted into the disc space.

In one embodiment of the device, all or portions of the device 1 aremanufactured using 3-D printing techniques. In another embodiment, allor portions of the device are made by injection molding techniques.

In one embodiment, the ratio of the surface area of the bottom tip ofthe plunger 12 is approximately half the surface area of the two lateralopenings at the distal portion of the hollow tube.

In one embodiment, the device 1 includes a supplemental means ofgripping the device, such as a laterally extending cylindrically-shapedhandle that engages the hollow tube 2.

In one embodiment, the material inserted into the hollow tube 2 is anon-Newtonian fluid. In one embodiment, the device 1 is adapted toaccept and deliver compressible fluids. In another embodiment, thedevice is adapted to accept and deliver non-compressible fluids. Thehollow tube 2 of one embodiment includes a rectangular lumen 28 whichprovides an increased cross-sectional footprint relative to a roundlumen of other bone graft delivery devices. The increasedcross-sectional footprint decreases friction of the non-Newtonian fluidmaterial against the interior walls of the lumen, resulting in animproved flow of bone graft material through the lumen and eliminating(or reducing) jamming due compression of the bone graft material. Theincreased cross-section of hollow tube 2 of the present disclosureimproves the flow dynamics of a non-Newtonian fluid by 40% compared to aprior art tool with a diameter equal to the height of the rectangularlumen of embodiments of the present invention.

In one embodiment, the upper portion of plunger 12 is fitted with one ormore protrusions, which extend from the surface of the plunger so as toengage the upper surface of the hollow tube, to prevent the plunger fromengaging the distal interior portion of the hollow tube. In oneembodiment, an upper portion of plunger 12 is fitted with one or moreprotrusions to prevent the plunger from engaging the apex of the hollowtube distal interior ramp surface.

In one embodiment, the funnel 30 attaches to the hollow tube 2 by abayonet connection. In one embodiment, the funnel 30 attaches to thehollow tube 2 by an interference fit. In one embodiment, the funnel 30attaches to the hollow tube 2 by a threaded connection. In oneembodiment, the funnel 30 attaches to the hollow tube 2 by a slot/grooveconnection.

In one embodiment, the distal end 8 of hollow tube has one opening 7. Inone embodiment, the hollow tube 8 has two distal openings 7A, 7B locatedon opposite sides. In one embodiment, the hollow tube has no more thantwo openings 7, the openings located on opposite sides.

In one embodiment, after bone graft material 44 is delivered to asurgical site 172, a cavity 174 approximately defined by the volumeengaged by the device 1 when inserted into the surgical site is left inthe surgical site upon removal of the device from the surgical site. Inone embodiment, the cavity 174 is then used as the site for insertion ofa fusion cage 60.

The integrated fusion cage 60 with expandable cage feature provides anumber of unique and innovative features not provided by conventional ortraditional integrated fusion cages. For example, the integrated fusioncage 60 with expandable cage feature of the present disclosure isintentionally and deliberately designed to receive bone graft material(or any material suitable for use in surgical applications, as known tothose skilled in the art) at its proximal end (i.e. the end generallyfacing the surgeon and/or the end opposite the end initially directedinto a surgical site), such that the bone graft material flows into thefusion cage and also flows out from the fusion cage into the surgicalsite. Such features as the interior ramps 9 of the fusion cage 60 (e.g.located within the interior of the hollow tube, and/or on the frontand/or rear blocks of the fusion cage) function to direct received bonegraft material into the surgical site. Additionally, the features of thehollow tube 2 and plunger 12 that enable a greater volume of bone graftmaterial to be reliably (e.g. not prone to blockage as is typical withmost convention e.g. round hollow tubes or lumen systems) and readilydelivered to a surgical site and/or a fusion cage are unique and notfound in the prior art. Among other things, such features encourageimproved surgical results by delivering more volume and coverage of bonegraft material to the surgical site. Also, such features minimize gapsin bone graft coverage to include gaps between the fusion cage area andthe surrounding surgical site. Also, the features of the one or moreapertures of the fusion cage of the disclosure enable and encouragedelivery of bone graft material, as received by the fusion cage, intothe surrounding surgical site.

In one embodiment of the fusion cage 60, no anti-torque structures orcomponents are employed. In one embodiment of the invention, the lateralsides of the fusion cage 60 are substantially open to, among otherthings, allow egress of bone graft material as received to the fusioncage. In one embodiment, the fusion cage has an expansion screwconfigured with a locking mechanism, such that the fusion cage 60 may belocked at a set expansion state. In one embodiment, such a lockingmechanism is provided through a toggle device operated at or on aninstaller/impactor handle.

In addition, it is contemplated that some embodiments of the fusion cage60 can be configured to include side portions that project therefrom andfacilitate the alignment, interconnection, and stability of thecomponents of the fusion cage 60.

Furthermore, complementary structures can also include motion-limitingportions that prevent expansion of the fusion cage 60 beyond a certainheight. This feature can also tend to ensure that the fusion cage isstable and does not disassemble during use.

In various embodiments, the aforementioned expansion screw canfacilitate expansion of the fusion cage 60 through rotation,longitudinal contract of a pin, or other mechanisms. The expansion screwcan also facilitate expansion through longitudinal contraction of anactuator shaft as proximal and distal collars disposed on inner andouter sleeves move closer to each other to in turn move the proximal anddistal wedged block members closer together. It is contemplated that inother embodiments, at least a portion of the actuator shaft can beaxially fixed relative to one of the proximal and distal wedge blockmembers with the actuator shaft being operative to move the other one ofthe proximal and distal wedge members via rotational movement orlongitudinal contraction of the pin.

Further, in embodiments wherein the engagement screw is threaded, it iscontemplated that the actuator shaft can be configured to bring theproximal and distal wedged block members closer together at differentrates. In such embodiments, the fusion cage 60 could be expanded to aV-configuration or wedged shape. For example, the actuator shaft cancomprise a variable pitch thread that causes longitudinal advancement ofthe distal and proximal wedged block members at different rates. Theadvancement of one of the wedge members at a faster rate than the othercould cause one end of the implant to expand more rapidly and thereforehave a different height that the other end. Such a configuration can beadvantageous depending on the intervertebral geometry and circumstantialneeds.

In other embodiments, an upper plate of the fusion cage can beconfigured to include anti-torque structures. The anti-torque structurescan interact with at least a portion of a deployment tool duringdeployment of the fusion cage implant to ensure that the implantmaintains its desired orientation. For example, when the implant isbeing deployed and a rotational force is exerted on the actuator shaft,the anti-torque structures can be engaged by a non-rotating structure ofthe deployment tool to maintain the rotational orientation of theimplant while the actuator shaft is rotated. The anti-torque structurescan comprise one or more inwardly extending holes or indentations on therear wedged block member. However, the anti-torque structures can alsocomprise one or more outwardly extending structures.

According to yet other embodiments, the fusion cage 60 is configured toinclude one or more additional apertures to facilitate osseointegrationof the fusion cage 60 within the intervertebral space. In variousembodiments, the fusion cage 60 contains one or more bioactivesubstances, including, but not limited to, antibiotics, chemotherapeuticsubstances, angiogenic growth factors, substances for accelerating thehealing of the wound, growth hormones, antithrombogenic agents, bonegrowth accelerators or agents, and the like. Indeed, various biologicscan be used with the fusion cage 60 and can be inserted into the discspace or inserted along with the fusion cage 60 The apertures canfacilitate circulation and bone growth throughout the intervertebralspace and through the implant. In such implementations, the aperturescan thereby allow bone growth through the implant and integration of theimplant with the surrounding materials.

In one embodiment, the fusion cage 60 comprises an expandable cageconfigured to move a first surface vertically from a second surface byrotation of at least one screw that rotates without moving transverselywith respect to either the first or second surface, the first plate andsecond plate having perimeters that overlap with each other in avertical direction and that move along a parallel line upon rotation ofthe screw.

Surprisingly, while conventional practice assumed that the amount ofmaterial that would be required, let alone desired, to fill a prepareddisc space with bone paste (or BMP, etc.) would be roughly equivalent tothe amount of material removed from such space prior to inserting acage, a present inventor discovered that far more bone graft materialcan be—and should preferably be—inserted into such space to achievedesired fusion results. The reasons why this basic under appreciationfor the volume of bone graft necessary to achieve optimal fusion resultsvary, but the clinical evidence arrived at via practice of the presentinvention compellingly demonstrates that more than doubling of theamount of bone graft material (and in some cases increasing the amountby 200%, 300% or 400% or more) than traditionally thought necessary orsufficient, is extremely beneficial to achieving desired results fromfusion procedures.

The ramifications of this simple yet dramatic discovery (documented inpart below) is part of the overall inventive aspect of the presentinvention, as it has been—to date—simply missed entirely by thepracticing spine surgeons in the field. The prospect of reduced returnsurgeries, the reduction in costs, time, and physical suffering bypatients, as well as the volume of legal complaints against surgeons andhospitals due to failed fusion results, is believed to be significant,as the evidence provided via use of the present invention indicates avast reduction in the overall costs involved in both economic resources,as well as emotional capital, upon acceptance and wide-spread use of thepresent invention. Insurance costs should thus decrease as the presentinvention is adopted by the industry. While the costs of infusingincreased amount of bone graft materials into the space of a patient'sdisc may at first appear to increase the costs of an individualoperation, the benefits achieved thereby will be considerable, includingthe reduction of repeat surgeries to fix non-fused spines. Thus,regardless of the actual tools and devices employed to achieve the endresult of attaining up to 100% more bone graft material being utilizedin fusion operations, (as well as other surgeries where previouslyunder-appreciated bone graft material delivery volumes have occurred)one important aspect of the present invention is directed to theappreciation of a previously unrecognized problem and the solutionthereto, which forms part of the inventive aspects of the presentinvention described and claimed herein.

In one embodiment, at least twice the amount of disc material removedfrom a surgical site is replaced with bone graft material. In apreferred embodiment, at least three times the amount of disc materialremoved from a surgical site is replaced with bone graft material. In amost preferred embodiment, at least three and a half times the amount ofdisc material removed from a surgical site is replaced with bone graftmaterial.

According to various embodiments of the present disclosure, and asillustrated at least by FIGS. 1-27, one aspect of the invention is toprovide a graft delivery device that comprises a tubular member, whichis substantially hollow or contains at least one inner lumen and thathas a generally rectangular cross-sectional shape. This generallyrectangular cross-sectional shape offers a larger amount of surface areathrough which bone graft material may be inserted and ejected from thehollow tubular member. Furthermore, this generally rectangular shape ismore congruent with the size or shape of the annulotomy of most discspaces, which frequently are accessed by a bone graft delivery devicefor delivery of bone graft. However, as one skilled in the art wouldappreciate, the tool cross-section need not be limited to a generallyrectangular shape. For example, cross-sections of an oval shape or thosewith at least one defined angle to include obtuse, acute, and rightangles can provide a shape in some situations that is more congruentwith the size or shape of the annulotomy of a particular disc space. Asubstantially round shape may also be employed that provides the surgeonwith an indication of directional orientation.

In embodiments, a distal end of the hollow tubular member may be atleast partially closed, and/or may have a small aperture associated withthe lumen. This partial closure and/or small aperture may help to createa consistent and clean break between bone graft material that has beenejected from the hollow tubular member and bone graft material heldwithin the hollow tubular member.

In another embodiment of the present disclosure the distal end of theplunger is flexible to allow, for example, the user to maneuver thedistal end and thereby any bone graft material in the hollow tube to theimplantation site. One skilled in the art will appreciate that theflexible aspect of certain embodiments can be both passive and active innature. Active flexibility and manipulation in the distal end of theplunger may incorporate, for example, the manipulative capabilities ofan endoscope, including components for manipulation such as guidewiresalong the longitudinal axis of the shaft of the plunger.

Another embodiment for the bone graft insertion device comprises ahollow tube constructed to receive bone graft, where the hollow tube hasa proximal and distal end, a plunger adapted for insertion at leastpartially within the hollow tube at the proximal end of the hollow tube,whereby the plunger is constructed and arranged with respect to thehollow tube so as to prevent rotation of the plunger during insertioninto the hollow tube, whereby the plunger has a distal end that iscontoured to an interior surface of the distal end of the hollow tubefor removing substantially all of the bone graft received by the hollowtube and whereby the bone graft is delivered to the graft receivingarea. Still another embodiment provides a rifling structure in thehollow tube interior that facilitates rotational movement of the plungeralong a lengthwise axis of the hollow tube, therein delivering asubstantially steady pressure and/or rate of delivery of the bone graftmaterial as the plunger descends the hollow tube when the plunger isforced through the hollow tube. The rifling or screw-like movement mayalso translate to a predetermined delivery of material per fullrotation, e.g. each 360 degree rotation of the plunger equates to 5 ccof bone graft material delivered to the bone graft site.

In embodiments, teeth may be formed along a longitudinal axis of theshaft of the plunger 12, which may be configured to engage with teeth ofthe grip 304 and/or knob 318 to facilitate advancement of the plunger 12when the grip 304 and/or knob 318 is actuated. The engagement of theteeth of the plunger 12 with teeth of the grip 304 and/or knob 318 maythus, by way of non-limiting example, form a rack-and-pinion-type linearactuator that causes the plunger 12 to descend the hollow tube 2 andurge bone graft material through the hollow tube 2 to deliver bone graftmaterial through an opening in a distal end of the hollow tube 2.

The indicia 29 may include one or more radiological or radiographicmarkers. Such radiological or radiographic markers may be made fromknown radiopaque materials, including platinum, gold, calcium, tantalum,and/or other heavy metals. At least one radiological or radiographicmarker may be placed at or near the distal end of the hollow tube 2, toallow radiological visualization of the distal end within the targetedbone area.

In further embodiments, an actuating means may be provided for applyingpressure to the plunger 12, and in particular to the shaft of theplunger 12. Upon actuation thereof, the actuating means may applypressure against the plunger 12 to facilitate controlled movement of theplunger 12 and/or the hollow tube 2 relative to the plunger 12. Theactuating means may, by way of non-limiting example, include a handleand a pivotally mounted trigger attached to a ratchet-type push bar(such as those commonly used with caulking guns) and/or arack-and-pinion-type linear actuator.

According to a still further aspect of the present invention, the distalend of the spinal fusion implant may have a conical (bullet-shaped)shape including a pair of first tapered (angled) surfaces and a pair ofsecond tapered (angled) surfaces. The first tapered surfaces extendbetween the lateral surfaces and the distal end of the implant, andfunction to distract the vertebrae adjacent to the target intervertebralspace during insertion of the spinal fusion implant. The second taperedsurfaces extend between the top and bottom surfaces and the distal endof the spinal fusion implant, and function to maximize contact with theanterior portion of the cortical ring of each adjacent vertebral body.Furthermore, the second tapered surfaces provide for a better fit withthe contour of the vertebral body endplates, allowing for a moreanterior positioning of the spinal fusion implant and thus advantageousutilization of the cortical rings of the vertebral bodies.

In other embodiments discussed above, the spinal fusion implant may beinserted into or through other sites including, but not limited to, acollapsed vertebra, or other appropriate sites known in the art. In suchembodiments, the implant can be used to create a void in the vertebrae,which is then filled with bone cement or other appropriate material.

While various embodiments of the present disclosure have been describedin detail, it is apparent that modifications and alterations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and alterations are withinthe scope and spirit of the present disclosure, as set forth in thefollowing claims.

The foregoing discussion of the disclosure has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the disclosure to the form or forms disclosed herein. In theforegoing Detailed Description for example, various features of thedisclosure are grouped together in one or more embodiments for thepurpose of streamlining the disclosure. This method of disclosure is notto be interpreted as reflecting an intention that the claimed disclosurerequires more features than are expressly recited in each claim. Rather,as the following claims reflect, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment. Thus, the followingclaims are hereby incorporated into this Detailed Description, with eachclaim standing on its own as a separate preferred embodiment of thedisclosure.

Moreover, though the present disclosure has included description of oneor more embodiments and certain variations and modifications, othervariations and modifications are within the scope of the disclosure,e.g., as may be within the skill and knowledge of those in the art,after understanding the present disclosure. It is intended to obtainrights which include alternative embodiments to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

1. A bone graft material delivery system, comprising: an elongate hollowtube configured to receive bone graft material, the elongate hollow tubehaving a longitudinal axis, an open proximal end, a distal end, and afirst opening at the distal end; a plunger adapted to extend in theelongate hollow tube, the plunger having a shaft and a distal portion,wherein the plunger is configured to urge the bone graft materialthrough the elongate hollow tube; and a first injection deviceconfigured to contain the bone graft material therein and to connect tothe open proximal end of the elongate hollow tube, whereby the bonegraft material may be discharged from the first injection device intothe elongate hollow tube.
 2. The delivery system of claim 1, wherein thefirst injection device is a first syringe.
 3. The delivery system ofclaim 1, wherein the bone graft material includes a first bone graftmaterial component and a second bone graft material component, and thefirst and second bone graft material components are mixed together priorto being discharged into the elongate hollow tube.
 4. The deliverysystem of claim 1, further comprising a second injection device that isconfigured to contain the bone graft material.
 5. The delivery system ofclaim 4, wherein the first injection device is a first syringe, and thesecond injection device is a second syringe.
 6. The delivery system ofclaim 4, further comprising a connecting device for interconnecting thefirst and second injection devices.
 7. The delivery system of claim 6,wherein the connecting device includes a bayonet mount.
 8. The deliverysystem of claim 6, wherein the connecting device includes at least oneLuer lock.
 9. The delivery system of claim 6, wherein the bone graftmaterial comprises a first bone graft material component and a secondbone graft material component, and wherein the first bone graft materialcomponent is located in the first injection device and a second bonegraft material component is located in the second injection device. 10.The delivery system of claim 6, wherein the connecting device includes abore extending through the connecting device and configured to enablemovement of the second bone graft material component from the secondinjection device to the first injection device to facilitate mixing thefirst and second bone graft material components within the firstinjection device.
 11. The delivery system of claim 1, further includingan implant configured to attach to the distal end of the elongate hollowtube and allow the bone graft material to pass through it.
 12. Thedelivery system of claim 11, wherein the implant is a bone fusion cage.13. The delivery system of claim 12, wherein the bone fusion cage isexpandable.
 14. The delivery system of claim 11, wherein the implantlaterally diverts the bone graft material that is delivered through it.15. A bone graft material delivery system, comprising: an elongatehollow tube configured to receive bone graft material, the elongatehollow tube having a longitudinal axis, an open proximal end, a distalend, and a first opening at the distal end; a plunger adapted to extendin the elongate hollow tube, the plunger having a shaft and a distalportion, wherein the plunger is configured to urge the bone graftmaterial through the elongate hollow tube; a first syringe containingthe bone graft material therein and configured to connect to the openproximal end of the elongate hollow tube, whereby the bone graftmaterial may be discharged from the first syringe into the elongatehollow tube; and an implant configured to attach to the distal end ofthe elongate hollow tube and allow the bone graft material to passthrough it.
 16. The delivery system of claim 15, wherein the bone graftmaterial includes a first bone graft material component and a secondbone graft material component, and further comprising a second syringecontaining the second bone graft material component and configured toconnect to the first syringe, and wherein the first syringe contains thefirst bone graft material component.
 17. The delivery system of claim16, further comprising a connecting device for interconnecting the firstand second syringes.
 18. The delivery system of claim 17, wherein theconnecting device includes a bore extending through the connectingdevice and configured to enable movement of the second bone graftmaterial component from the second syringe to the first syringe tofacilitate mixing the first and second bone graft material componentswithin the first syringe.
 19. The delivery system of claim 15, whereinthe implant is a bone fusion cage.
 20. The delivery system of claim 15,wherein the elongate hollow tube has a generally rectangularcross-section taken perpendicular to the longitudinal axis.